Despite European Nod, Novartis Gets FDA "Complete Response" For Indacaterol
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA requests additional dosing information for the chronic obstructive pulmonary disorder drug, also known as QAB149.
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A positive recommendation from the European Committee for Medicinal Products for Human Use for Novartis' respiratory drug indacaterol did not foreshadow similar regulatory ease from FDA: the firm announced Oct. 19 that is has received a "complete response" letter for the application. While the CHMP found the existing data package acceptable, FDA wants additional dosing information for indacaterol, also known as QAB149. It is an investigational once-daily bronchodilator proposed to treat adult patients with chronic obstructive pulmonary disease COPD. Novartis' announcement of the letter states that the firm will work with FDA to review the data already submitted, as well as data that has recently become available, to determine whether further clinical trials will be required. But CHMP issued a positive opinion on indacaterol in September supporting approval as a once-daily therapy with two doses (150 mcg and 300 mcg). That endorsement is the regulatory nod that precedes marketing approval in Europe. FDA's determination that the indacaterol application package is not sufficient for marketing approval - in the face of a different conclusion from the European authorities - is another case in an accumulating trend of drugs reaching the market with greater ease in Europe. For the past year, there has been growing concern about the possible return of a "drug lag," in which novel products get approved in the EU before they gain FDA approval. That issue had at one point been laid to rest by the user-fee program, but the increased focus on drug safety and workload burdens at FDA are causing some to speculate that the world of international approvals is changing (Also see ""Lagging Indicators": Is There A "Drug Lag" Between U.S. And Europe?" - Pink Sheet, 8 Sep, 2009.). The U.S. agency's decision to require additional dosing data for indacaterol - without indication that there is a fundamental efficacy or safety problem - is likely to provide fuel for that fire. It's also a significant setback for Novartis, though likely an easy one to fix. Indacaterol would be a major growth driver for Novartis' respiratory franchise, which also includes Xolair (omalizumab) and Foradil (formoterol fumarate). The firm estimates the COPD market to be a $9 billion opportunity, which is smaller than the asthma market but growing faster. Indacaterol is a lynchpin in Novartis' plans to grow its respiratory presence. In May, Novartis and Schering-Plough ended a respiratory product collaboration begun in 2002, with Novartis exiting the agreement with indacaterol in hand ( (Also see "Taking A Deep Breath: Novartis & Schering Split Respiratory Product Rights, Giving Novartis Indacaterol" - Pink Sheet, 25 May, 2009.), p. 11). The firms divvied up rights for investigational COPD and asthma products, leaving Novartis with another prospect for the indacaterol franchise: a fixed-dose combination of indacaterol and Schering's Asmanex (mometasone) (Also see "Schering/Novartis To Develop Once-Daily Inhalation Combination For Asthma, COPD" - Pink Sheet, 14 Aug, 2006.). -Jamie Hammon ([email protected]) |