Arena Pharmaceuticals Inc.
) recently received 'The Day 180 List of Outstanding Issues' from
the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP), in relation to its weight loss
drug, Belviq. Arena's shares were down significantly (almost 10%)
on the news.
Arena needs to discuss the issues with the CHMP before the
latter gives its final opinion on the marketing approval of
Belviq. The issues are both non-clinical and clinical in nature,
including tumors in rats, valvulopathy and psychiatric events.
The company has been asked to justify Belviq's overall
risk-benefit profile after considering the above issues.
Arena had filed a Marketing Authorization Application (MAA) to
the EMA for Belviq in Mar 2012. The company is looking to get the
product approved as an adjunct to diet and exercise for weight
control in overweight adults. The final opinion from the CHMP
regarding Belviq is expected in the first half of this year.
We remind investors that another obesity drug,
) Qsiva, also received a negative opinion from the CHMP in Oct
2012. The CHMP rendered a negative opinion due to concerns over
the potential cardiovascular and central nervous system effects
associated with the long-term use, teratogenic potential and use
by patients for whom Qsiva is not meant.
We expect investor focus to remain on the final opinion of the
CHMP on EU approval of Belviq.
We currently have a Zacks Rank #2 (Buy) on the stock.
), carrying a Zacks Rank #1 (Strong Buy), currently appear to be
more attractive in the pharma space.
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