Glaxo's Trametinib Delayed - Analyst Blog
May 02 2013 - 1:00PM
Zacks
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).
ATHERSYS INC (ATHX): Free Stock Analysis Report
CATALYST PHARMA (CPRX): Free Stock Analysis Report
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
UCB SA (UCBJF): Get Free Report
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