Merck & Co., Gilead Sciences, and GlaxoSmithKline Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Merck & Co., Gilead Sciences, and GlaxoSmithKline.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, July 19, 2017 to Tuesday, July 25, 2017.

Merck & Co. Wins Tentative Approval for Follow-on Basal Insulin
The US Food and Drug Administration (FDA) has granted tentative approval for Merck & Co.’s Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a prefilled dosing device. Lusduna Nexvue is being developed by Merck & Co. with funding from Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen.

With the tentative approval, Lusduna Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement. Lantus is Sanofi’s top-selling product with 2016 sales of EUR 5.71 billion ($6.66 billion).

Sanofi filed a patent-infringement suit against Merck Sharp & Dohme Corp. in the US District Court for the District of Delaware alleging the infringement of 10 patents related to its insulin products, Lantus (insulin glargine) and Lantus Solostar. The suit was triggered by a notification received from Merck & Co. in early August 2016, in which Merck stated it had filed a new drug application 505(b)2 with the FDA for an insulin glargine drug product.

Under the Hatch-Waxman Act, which created a statutory generic-drug approval process, the initiation of Sanofi’s lawsuit in September 2016 automatically invoked a stay on final FDA approval of Lusduna Nexvue for a period of up to 30 months, or in the event a court finds in favor of Merck, whichever comes sooner.

The trade name “Lusduna Nexvue” was granted provisional approval by the FDA and will be used in the US when the product is made available.

Source: Merck & Co.  

FDA approves Gilead’s Vosevi for Hepatitis C
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.

Vosevi is a fixed-dose, combination tablet containing two previously approved drugs–sofosbuvir and velpatasvir–and a new active ingredient, voxilaprevir. Vosevi is approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A. The FDA granted this application priority review and breakthrough therapy designations. 

Vosevi is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based direct-acting antiviral treatments that offer people living with HCV a short course of therapy to cure their HCV. Since 2013, Gilead has brought to market four HCV treatments, including three single-table regimens.

In 2016, Gilead’s HCV product sales, which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg), and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), were $14.8 billion for the full year 2016, compared to $19.1 billion in 2015. The declines were due to lower sales of Harvoni and Sovaldi, partially offset by sales of Epclusa, which was launched in 2016 across various locations.

Source: FDA and Gilead Sciences

FDA Approves GSK for a new self-injectable Lupus formulation
The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of GlaxoSmithKline’s (GSK) Benlysta (belimumab) for treating adult patients with active, autoantibody‑positive systemic lupus erythematosus (SLE) who are receiving standard therapy. SLE is a common form of lupus, a chronic, incurable autoimmune disease.

After training from their healthcare provider, patients will be able to administer the medicine as a once- weekly injection of 200 mg, from either a single-dose prefilled syringe or from a single-dose autoinjector.

This is the second formulation of Benlysta to be granted approval for SLE, adding to the existing intravenous (IV) formulation, approved in 2011, which is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinic setting every four weeks (following an initial loading phase given on days 0, 14, and 28).

Benlysta’s subcutaneous formulation will be available in specialty pharmacies in the US in late August 2017.

Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017.

Source: GlaxoSmithKline

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