Roche, Valeant Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche and Valeant.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 1, 2017 to Tuesday, November 7, 2017.

FDA OKs New Use for Roche’s Cancer Drug Zelboraf
The US Food and Drug Administration has expanded the approval of Roche’s Zelboraf (vemurafenib) to include treating certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood.

Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD, according to the FDA.

Zelboraf is a kinase inhibitor that works by blocking certain enzymes that promote cell growth.

The FDA granted this application priority review and breakthrough therapy designations for this indication. Zelboraf also received orphan-drug designation for this indication.

Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, now a member of the Daiichi Sankyo Group.

Zelboraf was first approved by the FDA in 2011 for treating unresectable or metastatic melanoma with BRAF (V600E) mutation as detected by an FDA-approved test

Source: FDA and Roche

Valeant Gets FDA OK for Eye-Care Drug
The US Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals’ new drug application (NDA) for Vylutza (latanoprostene bunod ophthalmic solution, 0.024%), a drug for treating eye pressure.

Vylutza, a prostaglandin analog with a nitric oxide metabolite, is indicated for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Vylutza was licensed on a global basis to Valeant’s Bausch + Lomb from Nicox, a ‎Sophia Antipolis‎, France-headquartered ophthalmic company. As a result of this approval, Nicox will receive $17.5 million from Bausch + Lomb and will make a $15-million payment to Pfizer under a previous license agreement.

The approval follows two Complete Response Letters from the FDA to Valeant in 2016 and 2017 regarding the NDA. The Complete Response Letters referred to a cGMP inspection at Valeant’s Bausch + Lomb’s manufacturing facility in Tampa, Florida. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA. 

Source: Valeant Pharmaceuticals


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