Recently, GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has extended the review period for Glaxo’s oncology candidate, trametinib, by three months. A final decision from the FDA on the marketing application of trametinib is now expected by Sep 3, 2013.
The FDA extended the review period in order to review additional manufacturing data submitted by Glaxo recently.
Glaxo is looking to get trametinib approved for the BRAF V600 mutation-positive metastatic melanoma indication. In Aug 2012, Glaxo submitted a new drug application (NDA) to the FDA for trametinib in the above mentioned indication.
In Europe, Glaxo submitted a regulatory application for trametinib as a monotherapy and in combination with another oncology candidate, dabrafenib, for the BRAF V600 mutation-positive metastatic melanoma indication in Feb 2013. Additional manufacturing data will also be shared with the European Medicines Agency (EMA).
In a separate development, Glaxo submitted an NDA to the FDA for its chronic obstructive pulmonary disease (COPD) candidate, umeclidinium bromide (UMEC). Glaxo has submitted the marketing application for the candidate in Europe as well. The company plans to submit regulatory applications in other countries during the course of the year.
Glaxo is working hard to develop its pipeline. A number of pipeline related news is expected in the coming quarters. We are encouraged by the progress of Glaxo’s pipeline. We are also pleased with Glaxo’s efforts to control cost and restructure operations. However, we remain concerned about the challenges faced by the company in the form of generic competition.
Glaxo carries a Zacks Rank #3 (Hold) in the short run. Companies that currently look attractive include UCB (UCBJF), Athersys, Inc. (ATHX) and Catalyst Pharmaceuticals Partners Inc. (CPRX). All three stocks carry a Zacks Rank #1 (Strong Buy).
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