Novartis, Momenta, Gilead Sciences, J&J Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis, Momenta Pharmaceuticals, Gilead Sciences, and Johnson & Johnson.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday February 7, 2018 date to Tuesday February 13, 2018.

FDA OKs Novartis’, Momenta’s Generic of Teva’s Blockbuster MS Drug Copaxone
The US Food and Drug Administration (FDA) has approved a generic version of Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection), a drug to treat multiple sclerosis (MS), from Sandoz, Novartis’ generics arm, and Momenta Pharmaceuticals, a Cambridge, Massachusetts-based biotechnology company. Copaxone had 2017 sales of $3.8 billion.

The FDA approved Glatopa (glatiramer acetate injection) 40 mg/mL as a fully substitutable generic version of Copaxone (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of MS. The companies also have a Glatopa 20 mg/mL dosage approved in the US. Sandoz launched the 20-mg formulation of the drug in 2015, and the companies subsequently filed an abbreviated new drug application with the FDA for the 40-mg formulation. Sandoz and Momenta have a collaboration agreement for Glatopa under which Sandoz is responsible for manufacturing.

The 40 mg/mL formulation was an important part of a generic-defense strategy for Copaxone. Teva launched the 40-mg/mL formulation of the product with a three-times a week dosing regimen following the patent expiration of a first-generation 20-mg/mL formulation with more frequent dosing. Patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched by Teva in the US in January 2014 and was approved in Europe in December 2015.

In February 2017, Sandoz and Momenta reported a delay in the regulatory review of the 40-mg formulation of the drug due to manufacturing issues of Pfizer, the contract manufacturer of the fill/finish of the product. Pfizer received a Warning Letter in 2017 following an FDA inspection of the facility. In February 2018, the FDA upgraded the status of Pfizer’s fill/finish manufacturing facility in McPherson, Kansas. The upgraded status lifted a compliance hold on approval of pending applications of products made at the facility.

Source: Novartis and Momenta Pharmaceuticals  

FDA OKs Gilead’s HIV Drug Biktarvy
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen for treating HIV-1 infection.

Gilead says Biktarvy combines the integrase strand transfer inhibitor, bictegravir, with the safety and efficacy profile of Gilead’s Descovy (FTC/TAF), a dual nucleoside reverse transcriptase inhibitor.

Biktarvy is indicated as a complete regimen for treating HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

Source: Gilead Sciences

FDA OKs New Use for J&J’s Cancer Drug Zytiga
The US Food and Drug Administration (FDA) has approved a new indication for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Zytiga (abiraterone acetate) in combination with prednisone for treating patients with metastatic high-risk castration-sensitive prostate cancer.

In November 2017, the European Commission granted approval to broaden the marketing authorization for Zytiga in combination with prednisone or prednisolone to include newly diagnosed high-risk metastatic hormone-sensitive prostate cancer. Similar submissions have been made in Japan, Canada, Mexico, Switzerland, Singapore, and the Philippines, and they were approved in Brazil and Taiwan. If approved, these submissions will broaden the use of Zytiga in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.

Zytiga in combination with prednisone is also indicated for treating patients with metastatic castration-resistant prostate cancer.

Source: Johnson & Johnson

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