The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued a positive opinion on GlaxoSmithKline’s (GSK - Free Report) Revolade.
The CHMP recommended the approval of Revolade for the treatment of thrombocytopenia (reduced platelet count) in adults with chronic hepatitis C virus (HCV) infection to enable the initiation of interferon-based therapy and achieve optimum results. Interferon-based therapies are commonly prescribed treatments for chronic HCV infection. We note that chronic HCV infection can cause several blood-related disorders including thrombocytopenia.
A final decision from the EU regulatory authorities on the approval of Revolade should be out by the end of this year. With the CHMP upholding a positive opinion, we expect Revolade to gain EU approval.
The positive CHMP opinion was based on encouraging safety and efficacy data from two randomized, double-blind, placebo controlled and multi-centre phase III studies, which enrolled more than 1,500 patients.
We remind investors that the U.S. Food and Drug Administration (FDA) has already approved the drug, marketed as Promacta, in the U.S. for the above mentioned indication in Nov 2012.
Promacta is also approved for idiopathic thrombocytopenic purpura, in both the U.S. and EU. Glaxo has a research & collaboration agreement with Ligand Pharmaceuticals Inc. (LGND - Free Report) for this drug.
Promacta sales came in at £45 million in the second quarter of 2013, up 53% from the year-ago period. We are pleased with Glaxo’s label expansion efforts, which should boost sales further.
Glaxo, a large cap pharma stock, presently carries a Zacks Rank #3 (Hold). However, another large cap pharma stock, Johnson & Johnson (JNJ - Free Report) , currently looks better positioned with a Zacks Rank #2 (Buy).
Other companies in the pharma space that are worth considering include Jazz Pharmaceuticals (JAZZ - Free Report) , which carries a Zacks Rank #1 (Strong Buy).