AstraZeneca, Merck & Co., Pfizer, and Roche Lead Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AstraZeneca, Merck & Co., Pfizer, and Roche.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday March 15, 2017 to Tuesday April 11, 2017.

AstraZeneca Gains FDA OK for Lung Cancer Drug
AstraZeneca has received full approval from the US Food and Drug Administration (FDA) for Tagrisso (osimertinib) 80mg once-daily tablets for treating non-small cell lung cancer (NSCLC).

Tagrisso’s approved indication is specifically for metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor therapy. The drug was granted fast track, breakthrough therapy, and priority review designations by the FDA and received accelerated approval for this indication in 2015 based on tumor response rate and duration of response.

Tagrisso 40mg and 80mg once-daily oral tablets have been approved in over 45 countries, including the US, EU, Japan, and China for this indication. Tagrisso is also being investigated in the adjuvant and metastatic first-line settings, including in patients with and without central nervous system metastases, in leptomeningeal metastases, and in combination with other treatments.

Source: AstraZeneca


Gilead’s Hep C Drugs Gain Expanded FDA Indication
The US Food and Drug Administration (FDA) has approved supplemental indications for Gilead Sciences’ hepatitis C drugs, Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets, for treating chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni and Sovaldi are Gilead’s top-selling anti-viral drugs with 2016 sales of $9.1 billion and $4 billion, respectively.

Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection and Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. Harvoni and Sovaldi each have a boxed warning in their respective product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV co-infected patients.

Source: Gilead Sciences


Janssen’s Anemia Drug Gains Extended Authorization in France
Janssen-Cilag International, a Johnson & Johnson company, has received extended authorization from the French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) for Eprex (epoetin alfa) for treating symptomatic anemia.

Eprex is now authorized to specifically treat symptomatic anemia (hemoglobin concentration of ≤10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes who have low serum erythropoietin (<200 mU/mL). The ANSM acted as the reference Member State within the Mutual Recognition Procedure (MRP). Upon the conclusion of the extension procedure within the MRP the other European health authorities are required to implement the new indication into their national Summary of Product Characteristics (SmPC) and package leaflet.

Eprex is an erythreopoiesis-stimulating agent for certain types of anemia, including chemotherapy-induced anemia and anemia due to chronic kidney disease. Eprex is currently indicated for treating symptomatic anemia associated with chronic renal failure; adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion; adults in a predonation program to increase the yield of autologous blood; and non-iron deficient adults prior to major elective orthopedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.

Source: Johnson & Johnson


Merck & Co.’s Keytruda Gains FDA OK for Hodgkin Lymphoma
Merck & Co. has received accelerated approval from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab), the company’s anti-programmed death-1 therapy, for treating refractory classical Hodgkin lymphoma. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Keytruda, which was approved by the FDA in 2014, is a blockbuster drug for Merck with 2016 sales of $1.4 billion.

In addition to treating refractory classical Hodgkin lymphoma, Keytruda is indicated in the US for treating unresectable or metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

Source: Merck & Co.


FDA OKs Merck KGaA’s/Pfizer’s Merkel Cell Cancer Drug
EMD Serono, the biopharmaceutical business of Merck KGaA, and Pfizer have received approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) Injection 20 mg/mL, for intravenous use, for treating metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response and duration of response.

Continued approval of Bavencio, a human anti-programmed death-L1 antibody, for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Bavencio was developed, reviewed, and approved through the FDA’s breakthrough therapy designation and priority review programs. Metastatic MCC is a rare and aggressive skin cancer.

Source: Pfizer


Mylan Launches Generic Version of Pfizer Breast Cancer Drug
Mylan has launched in the US Exemestane Tablets, 25 mg, a generic version of the reference listed drug, Pfizer’s Aromasin (exemestane) Tablets, a breast-cancer drug. Mylan received final approval from the US Food and Drug Administration for its abbreviated new drug application for its generic product, which is indicated in the treating certain types of breast cancer in women after menopause.

The launch of Exemestane Tablets, 25 mg, adds to Mylan’s oncology franchise. Exemestane Tablets, 25 mg, had US sales of approximately $100 million for the 12 months ending Jan. 31, 2017, according to QuintilesIMS and as cited by Mylan.

Source: Mylan


Mylan Receives Tentative FDA Approval for HIV Combo Anti-Viral
Mylan has received tentative approval from the US Food and Drug Administration under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its new drug application for efavirenz, lamivudine, and tenofovir disoproxil fumarate tablets, 400 mg/300 mg/300 mg, known as TLE400, an antiretroviral fixed-dose combination for treating HIV/AIDS. The drug will be available in developing countries as a first-line HIV/AIDS regimen.

Mylan’s TLE400 is formulated with a 400-mg dose of efavirenz, which is less than the standard dose of 600 mg and has been shown to be non-inferior to a dose of 600 mg when combined with tenofovir and emtricitabine during. TLE400 was recommended by the World Health Organization in 2016 as an alternative for first-line therapy for adults living with HIV.

Source: Mylan


Novo Nordisk Launches Fast-Acting Insulin in Canada
Novo Nordisk has launched Fiasp (fast-acting insulin aspart) in Canada for treating diabetes following the recent marketing authorization from Health Canada in January 2017. Following the launch in Canada, Fiasp will also be made available in a number of European markets in the coming months. Fiasp was developed by Novo Nordisk.

Fiasp also received marketing authorization from the European Commission in January 2017, covering all 28 European Union member states. Approval was also obtained in Norway and Iceland. The drug is currently under regulatory review in Australia, Switzerland, Brazil, South Africa, Argentina. and Israel.

In October 2016, Novo Nordisk received a Complete Response Letter from the US Food and Drug Administration regarding the new drug application for fast-acting insulin aspart. Following an evaluation of the CRL and ongoing discussions with the FDA, Novo Nordisk announced as part of the 2016 full-year results in February 2017 that a class II re-submission for fast-acting insulin aspart was expected within the next three months.

Source: Novo Nordisk 


EC Approves Pfizer’s RA Drug
The European Commission has approved Pfizer’s Xeljanz (tofacitinib citrate) 5 mg twice daily oral tablets in combination with methotrexate (MTX) for treating moderate to severe active rheumatoid arthritis. Xeljanz, a Janus kinase inhibitor, can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

Source: Pfizer 


FDA Expands Indication for Pfizer’s Breast Cancer Drug
The US Food and Drug Administration has approved a supplemental new drug application submitted by Pfizer for Ibrance (palbociclib), a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, which converts the accelerated approval of Ibrance to regular approval for treating a specific type of breast cancer.

The regular approval broadens the range of anti-hormonal therapy that may be administered with Ibrance, which is now indicated in combination with an aromatase inhibitor, expanding on its earlier indication in combination with letrozole, as initial endocrine-based therapy in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

In the US, Ibrance is indicated for treating HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy. Including the US, Ibrance is approved in more than 60 countries.

Source: Pfizer


EC OKs Label Extension for Shire’s Edema Drug
The European Commission has approved a label extension for Shire’s Cinryze (C1 inhibitor [human]), granting the drug three new indications and broadening its use to children with Hereditary angiodema (HAE), a rare, genetic disorder that results in recurring attacks of edema.

Cinryze is now indicated for routine prevention of angioedema attacks in children (ages 6 years and above) with severe and recurrent attacks of HAE who are intolerant to or insufficiently protected by oral preventions treatments, or patients who are inadequately managed with repeated acute treatment. Cinryze is also now approved for treating and preventing angioedema attacks in children (ages 2 years and above) with HAE.

Cinryze has been approved since 2011 for these indications in adults and adolescents ages 12-17 years with HAE. The drug will be available for use in pediatric patients later in 2017 throughout Member States of the European Union as well the European Economic Area in which Shire currently has a license in the adult and adolescent population.

Source: Shire


Teva Launches Authorized Generic of Combined Oral Contraceptive
Teva Pharmaceutical Industries has launched its authorized generic of Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) 1 mg/20 mcg in the US. Teva’s authorized generic of Minastrin 24 Fe is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

Minastrin 24 Fe had annual sales of approximately $361 million in the US according to IMS data as of December 2016 and as cited by Teva.

Source: Teva Pharmaceutical Industries


FDA OKs Tesaro’s PARP Inhibitor for Ovarian Cancer
Tesaro, a Waltham, Massachusetts-based oncology-focused biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for Zejula (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Tesaro anticipates launching Zejula in the US in late April 2017.

Source: Tesaro

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