AbbVie, Merck & Co., Novartis, and Roche Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, Merck & Co., Novartis, and Roche.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday December 14, 2016 to Tuesday January 10, 2017.

FDA Accepts Allergan’s sNDA for Contraceptive Drug
The US Food and Drug Administration (FDA) has accepted Allergan’s supplemental new drug application seeking approval to potentially extend the duration of use for the contraceptive drug, Liletta (levonorgestrel-releasing intrauterine system) 52 mg, in preventing pregnancy from up to three years to up to four years.

Source: Allergan


FDA Fast-Tracks Astellas’ Allergy Vaccine
The US Food and Drug Administration has granted fast track designation to Astellas Pharma’s peanut allergy vaccine, ASP0892. The compound, in Phase I development, is for the mitigation of severe hypersensitivity reactions due to peanut allergy.

ASP0892 is a new DNA vaccine program based on the investigational lysosomal associated membrane protein (LAMP)-Vax platform. LAMP is a glycoprotein found on the lysosomal membrane of a cell. A LAMP-Vax includes a short DNA sequence encoding this protein. A DNA vaccine stimulates an immune response against the protein by injecting the DNA encoding the protein rather than the protein itself. This allows DNA vaccines developed using the LAMP-vax platform to use the body’s natural biochemistry to develop a more complete immune response, according to Astellas.

Astellas partnered with Immunomic Therapeutics, a Rockville, Maryland-headquartered company that develops DNA vaccines, in January 2015. Immunomic granted Astellas the exclusive license for the Japan territory to develop and commercialize another investigational DNA vaccine, ASP4070, currently under clinical development to treat allergies to Japanese red cedar pollen. Following that agreement, both companies entered into an exclusive worldwide license agreement to the LAMP-Vax products in October 2015 for treating or preventing human allergic diseases.

Source: Astellas Pharma


AbbVie Submits Hep C Therapy Regimen to FDA
AbbVie has submitted a new drug application to the US Food and Drug Administration (FDA) for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated to treat chronic hepatitis C virus (HCV).

In September 2016, AbbVie received breakthrough therapy designation from the FDA for G/P for treating patients with HCV who were not cured with prior direct-acting antiviral (DAA) therapy in genotype 1, including therapy with a nonstructural protein 5A inhibitor (NS5A) and/or protease inhibitor.

The G/P regimen is being evaluated as a potential cure in eightweeks for HCV patients without cirrhosis and who are new to treatment. AbbVie is also studying G/P in patients with specific treatment challenges, such as Genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.

G/P is a once-daily regimen that combines two antiviral agents in a fixed-dose combination of glecaprevir (300mg), a nonstructural protein 3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.

Source: AbbVie


EMA Positive on New Dose Delivery of Amgen’s Cholesterol Drug
Amgen has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha (evolocumab), Amgen’s anti-cholesterol biologic. The product will be delivered in a new automated mini-doser (AMD) with prefilled cartridge, a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.

The positive opinion will be reviewed by the European Commission. If approved, marketing authorization will be extended to include the 420-mg single injection in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.

Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body’s natural system for eliminating low-density lipoprotein cholesterol (LDL-C), commonly known as “bad” cholesterol, from the blood.

Repatha was the first PCSK9 inhibitor to gain marketing authorization in Europe in July 2015 as an every-two-week or monthly dosing regimen. It was subsequently approved by the US Food and Drug Administration in August 2015. Repatha AMD will be available in Europe during 2017 depending on reimbursement requirements.

In Europe, Repatha is approved as an adjunct to diet for treating high cholesterol in combination with statins or other lipid-lowering therapies. It is indicated for use in patients who are unable to control their LDL-C with maximum tolerated statin doses. Repatha is also indicates in Europe alone or in combination with other lipid-lowering therapies to treat patients who are statin intolerant or for whom a statin is contraindicated. Repatha is also approved in combination with other lipid-lowering agents in patients with homozygous familial hypercholesterolemia (age 12 and over).

The biologics is approved in more than 40 countries, including the US, Japan, Canada, and in all 28 countries that are members of the EU. Applications in other countries are pending.

In the US, the FDA limited the Repatha indication to a subset of patients predisposed to high cholesterolemia at the limit of their statin therapy. Repatha in the US is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It is also indicated in the US as an adjunct to diet and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C.

Repatha is poised for blockbuster status, according to some analysts. Sales for Repatha in the first nine months of 2016 totaled $83 million.

Source: Amgen


EMA Positive on Adjusting Limits to GSK’s HIV Drug
ViiV Healthcare, a specialty HIV-focused pharmaceutical company with GlaxoSmithKline, Pfizer, and Shionogi as stakeholders, has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency to reduce the age and weight limit of patients being treated with the antiretroviral Tivicay (dolutegravir) for HIV infection.

Viiv had filed Type II and extension applications to reduce the weight and age limit of patients from 40 kg (88 lbs.) to 15 kg (33 lbs.) in ages six to less than 12 years old. With the applications, the company also registered new dose strengths for Tivicay of 10 mg and 25 mg oral tablets.

The variation indicates that the recommended dose for children from six to less than 12 years of age is to be determined according to the weight of the child, ranging from a 20 mg once-daily dose for children weighing between 15 kg (33 lbs.) and 20 kg (44 lbs.) to a 50 mg once-daily dose for children weighing 40kg (88 lbs.) or greater. This weight band-determined dosing reflects the World Health Organization guidelines on antiretroviral therapy for HIV infection in infants and children.

This CHMP positive opinion follows the US Food and Drug Administration’s (FDA) pediatric approval of the drug in June 2016 for a reduced age and weight limit.

Dolutegravir, the active ingredient in Tivicay, is an integrase strand-transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV. Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa, and Latin America.

The Tivicay brand name is a registered trademark of the ViiV Healthcare group of companies.

Source: GlaxoSmithKline


Janssen Seeks New Indications for Anti-Inflammatory Biologic
Janssen Biotech, a Johnson & Johnson company, has submitted two supplemental biologics license applications to the US Food and Drug Administration seeking approval of its anti-inflammatory agent, Simponi Aria (golimumab), for treating active psoriatic arthritis and active ankylosing spondylitis in adults.

Simponi Aria is a fully human anti-tumor necrosis factor (TNF)-alpha therapy that is currently approved as a 30-minute intravenous infusion for treating adults with moderately to severely active rheumatoid arthritis in combination with methotrexate. The biologic, discovered and developed by Janssen Biotech, targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that can cause inflammation and damage to bones, cartilage, and tissue when overproduced in the body due to chronic inflammatory diseases, according to Janssen.

Source: Johnson & Johnson


Lilly Gets Positive EMA Opinion on Rheumatoid Arthritis Drug
Eli Lilly and Company and Incyte, a Wilmington, Delaware-based pharmaceutical company, have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on granting marketing authorization to baricitinib, a once-daily oral drug, for treating moderate to severe active rheumatoid arthritis (RA). Baricitinib is a selective and reversible Janus kinase 1 (JAK1) and JAK2 inhibitor in clinical studies for inflammatory and autoimmune diseases.

If approved by the European Commission (EC), the drug would be marketed under the brand name Olumiant. The companies are seeking an indication specifically in treating moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.

A $65 million milestone payment to be paid by Lilly to Incyte will be triggered by the granting of marketing authorization by the EC, per a recent amendment to the parties’ agreement. Lilly and Incyte entered an exclusive worldwide license and collaboration agreement in December 2009 to develop and commercialize baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

Baricitinib was submitted for regulatory review seeking marketing approval for treating rheumatoid arthritis in the US, European Union, and Japan in the first quarter of 2016, and is being studied in Phase II trials for atopic dermatitis and systemic lupus erythematosus.

Source Eli Lilly and Company


Janssen Seeks OK in Adolescent Indication for Anti-Inflammatory Drug
Janssen Biotech, a Johnson & Johnson company, has submitted a supplemental biologics license application to the US Food and Drug Administration (FDA) seeking approval for its anti-inflammatory biologic, Stelara (ustekinumab), to treat severe plaque psoriasis in adolescents ages 12 to 17 years.

Stelara is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines. It was approved in the US in September 2009 to treat adults with moderate to severe plaque psoriasis.

In recent news, Stelara was approved by the European Commission in November 2016 for treating moderately to severely acting Crohn’s disease in adults.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to Stelara, which is currently approved for the treatment of moderate to severe plaque psoriasis in 87 countries, psoriatic arthritis in 71 countries. and pediatric psoriasis in 34 countries.

Source: Johnson & Johnson


EMA Recommends Merck & Co’s Keytruda for Lung Cancer
Merck & Co. has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending approval of Keytruda (pembrolizumab), the company’s anti-programmed death-1 (anti-PD-1) therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC).

Merck is seeking approval of Keytruda to treat NSCLC in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no endothelial growth factor receptor or anaplastic lymphoma kinase-positive tumor mutations.

A final decision from the European Commission is expected in the first quarter of 2017.

Keytruda is currently approved in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. In the US, Keytruda is indicated for melanoma, lung cancer, and head and neck cancer.

Keytruda was also recently approved in Japan for treating certain patients with PD-L1-positive unresectable advanced/recurrent NSCLC.

The product is poised to be a potential blockbuster for Merck, according to some analysts. Global sales for Keytruda in the first nine months of 2016 totaled $919 million.

Source: Merck & Co.


Novartis Gets Positive EMA Opinion on Seizure Medicine
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for Novartis’ Votubia (everolimus) dispersible tablets recommending approval of the drug for treating a particular type of seizure. Novartis is specifically seeking approval of the drug as an adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC).

In Europe, everolimus, the active ingredient in Votubia, has orphan drug designation for TSC. TSC is said to be a rare genetic disorder. Everolimus is believed to work by inhibiting a protein that regulates multiple cellular functions

In the European Union (EU), Votubia tablets are approved to treat adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications but who do not require immediate surgery. In the US, everolimus is approved as Afinitor tablets for the same indication. Afinitor tablets and Afinitor Disperz (dispersible tablets) are also indicated in the US in pediatric and adult patients with TSC for treating a brain tumor known as subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected.

Additionally, Afinitor tablets is approved in more than 110 countries, including the US and throughout the EU, for locally advanced, metastatic or unresectable progressive neuroendocrine tumors (NET) of pancreatic origin. It is also approved in the US and EU for treating adult patients with progressive, well-differentiated, nonfunctional NET of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic.

Afinitor is also approved in more than 120 countries including the US and EU for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor-targeted therapy (in the US, specifically following sunitinib and sorafenib). Afinitor is also approved in 115 countries including the US and EU for advanced HR+/HER2- breast cancer in combination with exemestane, after prior endocrine therapy.

Everolimus is also available from Novartis under the brand names Afinitor, Certican, and Zortress for use in oncology and transplant patient populations and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Source: Novartis


Novartis Receives Positive EMA Opinion for Rare-Disease Indication for Ilaris
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Novartis’ anti-inflammatory biologic, Ilaris (canakinumab), in Europe to treat three rare and distinct periodic fever syndromes. Ilaris is a human monoclonal antibody that inhibits Interleukin-1 beta, a part of the body’s immune system defenses.

If approved, Ilaris will be indicated in Europe for treating tumor necrosis factor-receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D dyndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF).

All three conditions are part of a group of rare autoinflammatory diseases called periodic fever syndromes, also referred to as hereditary periodic fevers. These can cause disabling and persistent fevers which may be accompanied by joint pain, swelling, muscle pain, and skin rashes with complications.

In August 2016, the European Commission approved Ilaris for a license extension to treat patients with adult-onset Still’s disease (AOSD), a rare type of inflammatory arthritis. The US Food and Drug Administration previously granted three simultaneous approvals of Ilaris for treating TRAPS, HIDS/MKD and FMF in September 2016.

Novartis has reformulated Ilaris from a powder that needed to be reconstituted into a solution prior to use to a ready-to-use solution for injection to ease administration of the product.

Ilaris is currently approved and marketed to treat systemic juvenile idiopathic arthritis (SJIA) in the US and EU and to treat AOSD and refractory acute gouty arthritis in the EU.

Ilaris is also approved in more than 70 countries, including in the EU, Switzerland, US, Canada, and Japan to treat cryopyrin-associated periodic syndromes (CAPS), a rare, genetic disorder. In the EU, Ilaris is approved to treat the following subtypes of CAPS: Muckle-Wells syndrome; neonatal-onset multisystem inflammatory disease/chronic infantile neurological, cutaneous, articular syndrome; and severe forms of familial cold autoinflammatory syndrome/familial cold urticaria presenting with signs and symptoms beyond cold-induced urticarial skin rash. The approved indications may vary depending upon the individual country.

Source: Novartis 


FDA Accepts Pfizer’s sNDA for Cancer Drug
The US Food and Drug Administration (FDA) has accepted for review and granted priority review status to Pfizer’s supplemental new drug application for its cyclin-dependent kinase (CDK) 4/6 inhibitor, Ibrance (palbociclib). Pfizer is seeking a conversion of the accelerated approval of Ibrance in combination with letrozole to regular approval as initial therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer.

This is the same patient population as the Phase II trial upon which the accelerated approval of Ibrance plus letrozole was granted in February 2015. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2017.

Ibrance is approved in more than 50 countries. In the US, it is indicated for treating HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.

Source: Pfizer


Roche’s Cancer Drug Recommended by EMA for Lung Cancer
Roche has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of its anti-cancer drug, Alecensa (alectinib), to treat a specific lung cancer.

The company is specifically seeking approval in the European Union for Alecensa to treat adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib. Based on the positive CHMP recommendation, a final decision regarding the conditional marketing authorization is expected from the European Commission in the coming months.

Alecensa as monotherapy is indicated for treating adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. It is approved in the US, Japan, Kuwait, Israel, Canada, Hong Kong, and South Korea to treat ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to crizotinib. In addition, the drug is being explored as a first-line treatment option in this specific form of lung cancer.

Source: Roche 


FDA Extends Review for Roche’s Multiple Sclerosis Biologic
The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act date for its review of Roche’s biologics license application of Ocrevus (ocrelizumab), a therapeutic being developed for multiple sclerosis, to March 28 2017 as the result of additional data submitted by Roche regarding the commercial manufacturing process for the biologic. The FDA requires additional time to review this data. The extension is not related to the efficacy or safety of Ocrevus.

Ocrevus is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to the damage of myelin and axonal nerve cells. It is in development for treating relapsing forms of multiple sclerosis and primary progressive multiple sclerosis.

Source: Roche

FDA Grants Roche Priority Review for New Bladder Cancer Indication
The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) from Roche and has granted priority review for its anti-cancer biologic, Tecentriq (atezolizumab), in an additional type of advance bladder cancer. Tecentriq was approved in May 2016 for urothelial carcinoma, the most common type of bladder cancer, according to the FDA.

The sBLA seeks approval for Tecentriq to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy and are either previously untreated (first-line), or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

The original FDA approval was for treating patients with locally advanced or mUC who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.

Tecentriq, a programmed death(PD)-1/PD-L1 inhibitor, is the first product in its class to be approved for urothelial carcinoma, according to the FDA. Tecentriq represents Roche’s first entry into PD-1 inhibitors and is poised to reach blockbuster status by 2019, according to some analysts.

Source: Roche 

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