Allergan, BMS, Gilead, and Pfizer Lead Drug Approvals

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Allergan, BMS, Gilead, and Pfizer.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 9, 2016 to Tuesday November 15, 2016.

Allergan Launches Oral Contraceptive Softgel Capsules
Allergan has launched Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1 mg/20 mcg, an oral contraceptive in a softgel capsule for the prevention of pregnancy. Taytulla will be commercially available in blister cards containing 24 soft gelatin capsules, each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol, and four capsules containing iron.

Source: Allergan

FDA OKs BMS’ Opdivo for Head and Neck Cancer
Bristol-Myers Squibb has received approval from the US Food and Drug Administration (FDA) for Opdivo (nivolumab) injection, for intravenous use in treating patients with head and neck cancer. The new indication is for treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

In addition to the new indication in SCCHN treatment, Opdivo as a single agent is indicated in the US for treating BRAF V600 mutation-positive unresectable or metastatic melanoma and BRAF V600 wild-type unresectable or metastatic melanoma. As a combination therapy, it is indicated in combination with Yervoy (ipilimumab) for treating unresectable or metastatic melanoma.

Other indications in the US for Opdivo include treatment of: metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy; advanced renal cell carcinoma with prior anti-angiogenic therapy; and classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

Opdivo has been pegged as a future blockbuster drug some analysts. In 2015, it had global sales of $942 million, and a recent Thomson Reuters analysis projects that 2019 sales will reach nearly $8.9 billion.

Source: Bristol-Myers Squibb

Gilead Gets FDA OK for Hep B Drug
Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease. Vemlidy is a targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 300mg, according to Gilead.

Viread was approved by the FDA in October 2001 and is indicated in combination with other antiretroviral agents for treating human immunodeficiency virus-1 infection in adults and pediatric patients 2 years of age and older and for treating chronic hepatitis B in adults
and pediatric patients 12 years of age and older.

Viread is one of Gilead’s top-10 selling drugs with 2015 sales of $1.1 billion. The patent for the drug in the US expires in 2018, and in Europe it expires in 2017.

In related news, Gilead’s Vemlidy was recommended for approval in Europe by the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency.

See related story here.

Source: Gilead Sciences

Pfizer’s Breast Cancer Drug Gets Approval in EU
Pfizer has received approval from the European Commission for Ibrance (palbociclib) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval is for Ibrance to be used in combination with an aromatase inhibitor. The approval also covers the use of the drug in combination with fulvestrant in women who have received prior endocrine therapy.

Ibrance is an oral inhibitor of cyclin-dependent kinases 4 and 6,7 which are regulators of the cell cycle that trigger cellular progression, the company said. The drug is now 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 

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