Novartis (NVS) announced that the FDA has extended the priority review period for the new drug application (NDA) for LBH589 by up to 3 months. The company is looking to get LBH589 (in combination with Velcade and dexamethasone) approved for treatment-experienced patients suffering from multiple myeloma.
This is not surprising since earlier this month, the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted against approving LBH589 for treatment-experienced patients suffering from multiple myeloma. Although the FDA is not compelled to follow its advisory panel’s recommendations, it usually does so.
Meanwhile, several companies are developing therapies for the treatment of multiple myeloma. AbbVie (ABBV) and Bristol-Myers Squibb’s (BMY) are jointly evaluating elotuzumab for the treatment of multiple myeloma in treatment-experienced patients.
Our Take
The extension of priority review period for LBH589 is concerning. We are not confident about the chances of LBH589 gaining approval given the ODAC’s negative recommendation for the candidate.
The successful development of LBH589 would have significantly boosted Novartis’ portfolio, which is presently facing generic competition for a number of products including Zometa and Diovan mono. Additionally, the patent covering Gleevec is slated to expire in 2015 in the U.S. and in 2016 in the major European countries.
Meanwhile, Novartis is submitting a rolling NDA for LCZ696 for heart failure in the U.S., which is expected to be completed by the end of 2014. The company intends to file for its approval in this indication in Europe in early 2015.
Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharmaceutical sector is Allergan (AGN), carrying a Zacks Rank #1 (Strong Buy). AbbVie holds a Zacks Rank #2 (Buy).
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