Novartis has snapped in the last piece of an intricate and ambitious data puzzle for QVA149 and says it all points to near-term regulatory filings for the combo LAMA/LABA lung drug in Europe and Japan. But while the regulatory pathway in Europe looks clear of major obstacles, Novartis ($NVS)--which has long had blockbuster expectations for this treatment--may find itself in an uphill battle with payers comparing it with other available treatments. And the developers continue to struggle with dosing issues in the U.S. which will delay the program for another two years.
With the success of its Phase III SPARK study, Novartis now has a considerable body of efficacy and safety data to take to regulators. "We are very pleased that SPARK showed a reduction of exacerbations, further demonstrating that QVA149 could improve the lives of patients with COPD," said Tim Wright, the development chief at Novartis. "We are looking forward to filing QVA149 initially in Europe and Japan, which will bring us another step closer to providing a full range of innovative COPD medicines to help physicians select the right treatment for the right patient at the right time."
A U.S. filing is expected by the end of 2014.
Bank Vontobel analyst Andrew Weiss wasn't overwhelmed by the case Novartis is making. "Without superiority to (Boehringer Ingelheim's) Spiriva, we doubt this data will give QVA an edge," he told Reuters. Spiriva earned $4.4 billion last year.
QVA149 is a combination of indacaterol and NVA237, which faced delays in the U.S. Novartis has had its sights set on Advair, GlaxoSmithKline's ($GSK) big COPD drug. GSK and Theravance ($THRX) recently filed for U.S. approval of their new COPD treatment, Relovair, which has produced mixed data in clinical studies. Forest Labs recently gained approval for a new COPD treatment, though most analysts expect it to garner only modest sales. And several other biotechs, including Pearl Therapeutics, have their own programs underway.
- here's the release
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