Biotech Values

[DewDiligence]

NVS—FDA Panel Rejects High-Dose QAB149 by 12-5 Vote

[The advisory panel endorsed the low (75mcg) dose of QAB149 by a 13-4 vote; however, the high (150mcg) dose of QAB149 is highly consequential to NVS’ commercial prospects because it’s the dose NVS is testing in a combination drug for COPD known as QVA149 (#msg-60523825). QVA149 consists of QAB149 (f/k/a Indacaterol, Onbrez Breezhaler), a LABA, and NVA237, a LAMA. The advisory panel’s rejection of the high dose of QAB149 as monotherapy suggests that QVA149 will have some headwinds to overcome in its own review even if the QVA149 phase-3 trials are successful.

The PDUFA date for QAB149 monotherapy is 4/1/11.]

http://www.reuters.com/article/2011/03/08/novartis-lung-idUSN0819490620110308

›Tue Mar 8, 2011 4:37pm EST

SILVER SPRING, Md., March 8 (Reuters) - The higher dose of a proposed Novartis (NVS) lung drug should not be approved, U.S. government advisers said on Tuesday in a 12-5 vote.

The Food and Drug Administration advisory panel voted 13-4 to recommend approval of the lower, 75-microgram dose of the inhaled drug, indacaterol, for treating chronic obstructive pulmonary disease.

Industry analysts say the higher dose is key because Novartis is testing it as part of a two-in-one medicine the company is studying that could bring blockbuster sales.

The FDA usually follows panel recommendations. A final decision is due by April 1.‹