New Drug Approvals

MAA EU =marketing authorisation application EU

MAR 08 2013

GSK submits diabetes drug albiglutide in EU

GlaxoSmithKline has announced the submission of a marketing authorisation application for albiglutide, which will have the brand name Eperzan, to the European Medicines Agency.

The filing of albiglutide, a once-weekly treatment for type 2 diabetes, comes almost two months after it was filed in the USA. The drug is a GLP-1 receptor agonist, the same class of injectable treatments dominated by Novo Nordisk’s once-a-day Victoza (liraglutide), twice-daily Byetta (exenatide) and an extended-release formulation of the latter, Bydureon. They were developed and sold by Amylin, which was then acquired by  Bristol-Myers Squibb and AstraZeneca.

The filing is based in part on a study which assessed albiglutide against Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin) which showed that GSK’s drug showed clinically and statistically significant reductions in HbA1c from baseline and superiority versus the US firm’s diabetes blockbuster. However in data from a…

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New Drug Approvals

File:PSI-7977.svg

Sofosbuvir

Isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate

hepatitis c

The Foster City, CA-based Gilead said that its experimental drug GS-7977, originally known as PSI-7977 before the acquisition, when combined with ribavirin, cured a group of genotype 1 hepatitis C patients after four weeks of treatment. The clinical study involved hepatitis C patients who either failed to respond to previous therapies or had not been treated before. The genotype 1 is the most common form of HCV in the United States. It affects 70 to 90 percent of the people in this country who have hepatitis C.

Norbert Bischofberger, chief scientific officer at Gilead said patients with genotype 1 hepatitis C had no detectable signs of the virus after treated with GS-7977 combination therapy for a course of close to a month. Previous study showed the drug candidate could also cure patients with genotype 2 and 3 HCV.

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