Gilead, Lilly, Merck & Co., and Pfizer Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Gilead, Eli Lilly and Company, Merck & Co. , and Pfizer.

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 OKs Biogen’s Spinal Muscular Atrophy Drug
Biogen has received US Food and Drug Administration approval for Spinraza (nusinersen) under priority review for treating spinal muscular atrophy (SMA) in pediatric and adult patients. The FDA issued Biogen a rare pediatric disease priority review voucher with the approval of Spinraza.

Biogen licensed the global rights to develop, manufacture, and commercialize Spinraza from Ionis Pharmaceuticals, a pharmaceutical company headquartered in Carlsbad, California, which is focused on antisense therapeutics. Based on the FDA approval, Ionis will receive a $60-million milestone payment. Ionis is also eligible to receive tiered royalties on any potential sales of Spinraza up to a percentage in the mid-teens.

In Europe, the European Medicines Agency (EMA) validated Biogen’s marketing authorization application for Spinraza in October 2016 for treating SMA, and the EMA’s Committee for Medicinal Products for Human Use granted the application accelerated assessment status. Biogen has also submitted regulatory filings in Japan, Canada, and Australia and will initiate additional filings in other countries in 2017.

Spinraza is an antisense oligonucleotide that is designed to treat SMA caused by mutations in the chromosome 5q that leads to survival motor neuron protein deficiency. Spinraza is administered via intrathecal injection, which delivers therapies directly to the cerebrospinal fluid around the spinal cord where motor neurons degenerate in patients with SMA due to insufficient levels of SMN protein.

Source: Biogen

Genentech Gets FDA OK for Expanded Eye-Disease Indication
Genentech, a member of the Roche Group, has received approval from the US Food and Drug Administration for an expanded indication that allows its eye-disease drug, Lucentis (ranibizumab injection) 0.5 mg, to treat patients with myopic choroidal neovascularization, a complication of severe near-sightedness. This is the fifth FDA-approved indication for Lucentis since its launch in 2006.

Lucentis is approved for treating wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and now myopic choroidal neovascularization. Lucentis was developed by Genentech, which retains commercial rights in the US. Novartis has exclusive commercial rights for the rest of the world.

Source: Genentech

Gilead’s Hep B Drug Approved in Japan
Gilead Sciences has received approval in Japan from the Japanese Ministry of Health, Labor, and Welfare for its hepatitis B drug, Vemlidy (tenofovir alafenamide) 25 mg. Vemlidy was approved as a once-daily treatment for suppressing viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. Gilead is preparing to launch Vemlidy as quickly as possible.

Vemlidy is a targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate (TDF) 300 mg, according to Gilead. In Japan, the drug will compete with TDF, which is sold in that country by GlaxoSmithKline.

Gilead’s regulatory pathway for Vemlidy was earlier boosted by the US Food and Drug Administration’s approval of the drug and a positive opinion in the European Union issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use, both in November 2016.

Source: Gilead Sciences 

Lilly, BI Launch Follow-On Insulin to Lantus
Eli Lilly and Company and Boehringer Ingelheim (BI) have launched their diabetes therapy, Basaglar (insulin glargine injection 100 units/mL), which is now available by prescription in the US. Basaglar is a follow-on insulin to Lantus (insulin glargine), Sanofi’s top-selling product. Basaglar is a long-acting insulin with an amino acid sequence identical to Lantus, according to Lilly and BI.

In December 2015, the US Food and Drug Administration (FDA) approved Basaglar as a long-acting insulin used to control high blood sugar in adults and children with Type 1 diabetes and adults with Type 2 diabetes. However, per a settlement agreement with Sanofi, Basaglar was to be made available in the US starting on December 15, 2016. Basaglar is available by prescription from retail and mail order pharmacies in the US.

Basaglar is among the generic competitors that Sanofi’s Lantus is facing as the blockbuster product loses its patent exclusivity. In August 2016, the FDA accepted a new drug application from Merck & Co. for its investigational follow-on biologic of insulin glargine, MK-1293, which will also compete with Lantus.

Lantus had global sales of EUR 3.541 billion ($3.683 billion) in the first nine months of 2016 and 2015 sales of EUR 6.390 billion ($6.633 billion).

Source: Eli Lilly and Company

Merck & Co.’s Keytruda Approved in Japan for Lung Cancer
Merck & Co., known as MSD outside the United States and Canada, has received approval in Japan from the Japanese Ministry of Health, Labor, and Welfare for its anti-cancer biologic Keytruda (pembrolizumab), to treat a specific type of lung cancer.

The approval in Japan is for the use of Keytruda to treat certain patients with programmed death-ligand 1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first- and second-line treatment settings. Dosing is fixed at 200 mg every three weeks. MSD will manufacture and market Keytruda in Japan and will promote it with Taiho Pharmaceutical.

Keytruda is poised for blockbuster potential, some analysts say. Total sales in the first nine months of 2016 totaled $919 million.

In the US, Keytruda is indicated for melanoma, lung cancer, and head and neck cancer and was approved by the European Commission to treat locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.

Keytruda made further strides in Europe this month when the drug received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending its approval in the first-line treatment of metastatic NSCLC in adults whose tumors have high PD-L1 expression with no endothelial growth factor receptor or anaplastic lymphoma kinase-positive tumor mutations.

Source: Merck & Co.

Mylan Launches Generic EpiPen
Mylan has launched an authorized generic for EpiPen (epinephrine injection, USP) Auto-Injector at a wholesale acquisition cost (WAC) of $300 per epinephrine injection USP two-pack. The company noted that this price is more than 50% lower than the WAC of branded EpiPen 2-Pak Auto-Injectors.

The authorized generic has the same drug formulation and device functionality as the branded EpiPen Auto-Injector and will be available through retail channels in 0.15 mg and 0.3 mg strengths, the company said.

To further increase access to treatment, Mylan has launched an additional patient purchase option at $300 per two-pack. Mylan also is offering a savings card for eligible patients with commercial health insurance, providing up to $25 off the out-of-pocket cost for the authorized generic. The company will also continue to offer its patient assistance program to support uninsured and underinsured patients.

Mylan had been facing increased government scrutiny over the pricing of its branded EpiPen Auto-injector, which had been called out in August 2016 by two US senators. In October 2016, the company settled with the US Department of Justice and other government agencies in regards to Medicaid rebate liability claims.

Source: Mylan

Mylan Launches Generic Oral Contraceptive
Mylan has launched in the US its generic version of the oral contraceptive drug, Zovia 1/50E-28 tablets (ethinyl estradiol; ethynodiol diacetate), manufactured by Watson Pharmaceuticals, now Allergan.

Mylan’s product, ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/0.05 mg, was determined to be bioequivalent and therapeutically equivalent to Zovia 1/50E-28 tablets. Mylan’s subsidiary, Jai Pharma, received final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for this product, which is indicated for use by women to prevent pregnancy.

Source: Mylan

Mylan Launches Generic Anti-Epilepsy Drug
Mylan has launched in the US its generic version of Pfizer’s anti-epilepsy drug, Cerebyx injection (fosphenytoin sodium).

Mylan received final approval from the US Food and Drug Administration for its abbreviated new drug application for fosphenytoin sodium injection USP, 75 mg/mL, (50 mg phenytoin sodium equivalents (PE)/mL), packaged in 100 mg PE/2 mL and 500 mg PE/10 mL single-use vials, for treating certain types of severe seizures.

This product is part of Mylan’s portfolio of more than 450 injectable products, which includes liquid, lyophilized, and dry-powder formulations.

Source: Mylan

Mylan Launches Generic ADHD Drug
Mylan has launched in the US its generic version of Concerta (methylphenidate hydrochloride) tablets, a drug for treating attention deficit hyperactivity disorder (ADHD) by Janssen, a Johnson & Johnson company. Mylan received final approval from the US Food and Drug Administration for its abbreviated new drug application for its product, methylphenidate hydrochloride extended-release tablets USP, 18 mg, 27 mg, 36 mg and 54 mg. Mylan’s product is indicated to treat ADHD.

Janssen’s Concerta had $821 million in 2015 sales and $659 million in sales for the first nine months of 2016.

Methylphenidate hydrochloride extended-release tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, had US sales of approximately $1.59 billion for the 12 months ending October 31, 2016, according to QuintilesIMS and as cited by Mylan.

Source: Mylan

EC OKs Novo Nordisk’s Fast-Acting Insulin
Novo Nordisk has received marketing authorization from the European Commission for Fiasp (insulin aspart), a fast-acting insulin for treating Type 1 and Type 2 diabetes. The authorization covers all 28 European Union member states.

Novo Nordisk expects to launch the drug in the first European countries in the first half of 2017. Fiasp will be will be available in vial, Penfill, and FlexTouch pen.

Fiasp is a new formulation from Novo Nordisk’s NovoRapid (insulin aspart), in which two new excipients have been added to enhance absorption and provide earlier insulin action, according to the company. Fiasp also received marketing authorization from Health Canada on January 6, 2017, and has been filed for regulatory review in the US, Switzerland, Australia, Canada, Brazil, South Africa and Argentina.

Source: Novo Nordisk

Perrigo Gets FDA OK for OTC Nicotine Gum
Perrigo has received approvals from the US Food and Drug Administration for abbreviated new drug applications referencing GlaxoSmithKline‘s Nicorette White Ice Mint Gum (nicotine polacrilex gum 2 mg and 4 mg). These products will be packaged and marketed as store brands or retailer ‘own label’ brands and provide alternatives to Nicorette White Ice Mint Gum.

Nicorette White Ice Mint Gum is used to help patients quit smoking by reducing nicotine withdrawal symptoms.

Source: Perrigo 

Pfizer Gets FDA OK on Eczema Ointment
Pfizer has received US Food and Drug Administration approval for Eucrisa (crisaborole) ointment 2% for treating eczema.

Eucrisa is a non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor. The approval was specifically for the treatment of mild to moderate atopic dermatitis (AD), commonly known as eczema, in patients two years of age and older.

Overactive PDE-4 has been shown to contribute to the signs and symptoms of AD, according to Pfizer.

Source: Pfizer 

Pfizer Gets EC OK on Meningitis Vaccine
Pfizer has received approval from the European Commission for an expanded indication to its meningitis vaccine, Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine).

Nimenrix was approved for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. Nimenrix can now be administered in the European Union (EU) at six weeks of age with no upper-age limit.

Nimenrix is a MenACWY conjugate vaccine that uses tetanus toxoid as a carrier protein. It was first approved in the EU on April 2012 and is licensed in more than 65 countries, including the countries across the EU, Brazil, Chile, Kuwait, Qatar, Turkey and the United Arab Emirates.

Source: Pfizer

FDA Updates Label on Pfizer’s Smoke-Cessation Drug
The US Food and Drug Administration (FDA) has approved updates to the labeling of Pfizer’s smoke-cessation drug, Chantix (varenicline), including removal of the boxed warning regarding serious neuropsychiatric events.

The updated warning in the Chantix labeling notes that post-marketing reports of serious or clinically significant neuropsychiatric adverse events in patients treated with Chantix included changes in mood, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. The updated labeling directs patients attempting to quit smoking with Chantix to be observant for the occurrence of such symptoms and instructs patients to discontinue use and contact a healthcare provider if they experience such symptoms.

Chantix, sold under the name Champix in the European Union and other countries, was approved by the FDA in May 2006 as a prescription medication that, along with support, helps adults 18 and over stop smoking. Chantix is approved in more than 100 countries.

Source: Pfizer 

Sanofi Launches Long-Acting Insulin
Sanofi has launched Soliqua 100/33 (insulin glargine 100 units/mL and lixisenatide 33 mcg/mL injection), its combination regimen for treating Type 2 diabetes. Soliqua was approved by the US Food and Drug Administration in November 2016.

Soliqua joins Sanofi’s diabetes franchise, which is a leading business for the company at EUR 7.58 billion ($8.03 billion) in 2015 revenues. Sanofi’s diabetes franchise has been facing generic competition for its top-selling product, Lantus (insulin-glargine), a long-acting insulin. Lantus had 2015 sales of EUR 6.39 billion ($6.77 billion).

Source: Sanofi

Shire Gets FDA OK for Hemophilia Therapy
Shire has received approval from the US Food and Drug Administration (FDA) for Adynovate [antihemophilic factor (recombinant), PEGylated], to treat hemophilia A in pediatric patients under the age of 12. The FDA also approved Adynovate for use in surgical settings for both adult and pediatric patients.

Adynovate is an extended circulating half-life recombinant Factor VIII (rFVIII) hemophilia A treatment. It is built on the full-length Advate [antihemophilic factor (recombinant)] molecule, a hemophilia A treatment that has been on the market for 13 years. Adynovate was first approved by the FDA in November 2015.

Source: Shire

FDA OKs Clovis Cancer Drug with Accelerated Approval
Clovis Oncology, a Boulder, Colorado-based biopharmaceutical company, has received US Food and Drug Administration (FDA) approval for Rubraca (rucaparib) tablets as a monotherapy to treat ovarian cancer. Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor.

The drug’s specific indication is as a monotherapy to treat patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Rubraca’s indication is approved under the FDA’s accelerated approval program.

Clovis partnered with Foundation Medicine, a Cambridge, Massachusetts-based cancer diagnostics company, in August 2012 to co-develop a companion diagnostic test, the FoundationFocus CDxBRCA, which is approved by the FDA. Clovis will use this diagnostic test to select patients for Rubraca treatment. FoundationFocus CDxBRCA is a tissue-based, genomic assay that detects tumor BRCA1 and BRCA2 mutations (germline and/or somatic) in ovarian cancer.

In October 2016, Clovis formed a long-term commercial supply agreement with Lonza, which will construct a new production train in its Visp, Switzerland plant to manufacture the active ingredient, rucaparib. The new train is expected to be completed and operationally qualified by early 2019.

Clovis’ Rubraca joins another PARP inhibitor for advanced ovarian cancer in the market, AstraZeneca’s Lynparza (olaparib), which received FDA and European Commission approval in December 2014. AstraZeneca’s drug was the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer as detected by an FDA-approved companion diagnostic test, BRACAnalysis CDx. Lynparza had 2015 sales of $94 million and $156 million in sales for the first nine months of 2016.

Pfizer also has a PARP inhibitor in late-stage development that it gained through its $14-billion acquisition of Medivation, a San Franciso-based biopharmaceutical company, in September 2016. The candidate, talazoparib, is currently in a Phase III study for the treatment of BRCA-mutated breast cancer. It has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors, according to Pfizer.

Source: Clovis Oncology

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