) 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,
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
Catalyst Pharmaceuticals Partners Inc.
). All three stocks carry a Zacks Rank #1 (Strong Buy).
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