Monday, November 8, 2010

Merck Just Withdrew European Zenhale® (Dulera® Aerosol) Approval Application, On Friday

One quick surprise -- in the just filed Merck Form 10-Q -- the aerosol fixed dose combination called Dulera® here (approved in June 2010 by FDA), and proposed to be sold as Zenhale® in Europe, has been withdrawn by Merck from the approval cue, at the EMEA -- the European medicines agency.

From page 48, then:

. . . .On November 5, 2010, the Company advised the European Medicines Agency (“EMA”) that it was withdrawing the application for marketing authorization for Zenhale, a fixed dose combination of mometasone furoate and formoterol fumarate dihydrate, which has been approved for use in asthma patients 12 years of age and older in the United States as Dulera Inhalation Aerosol. The Company decided to withdraw the application for Zenhale to address questions outstanding between the Company and the Committee for Medicinal Products for Human Use of the EMA. The Company expects to resubmit the application in the future. . . .

We'll keep you posted, though market-uptake of the Dulera combination has been, thus far, markedly slow, in the United States. That is likely due to the fact that Dulera contains a long acting beta2-adrenergic agonist, or a LABA, for short. The FDA stepped up the "black box" warnings on LABAs last summer.


Anonymous said...

When a company withdraws an application it typically means that there has been communication to expect a turndown. A withdrawal is thus a face saving move that tends not to hurt the stock price as much.

This isn't the only time there has been discrepancies the EMEA also found that asenapine (Saphris) didn't have adequate evidence of efficacy in schizophrenia whereas the FDA did.

Based on the discrepancy in outcomes between the EMEA and FDA it makes you wonder what is going on at the FDA.


condor said...

Exactly -- re face-saving. Couldn't have said it better, myself Salmon.


Anonymous said...

also remember this is now, at least, 3rd 'in-class' of inhaled steroid and LABA.

Anonymous said...

Hard to see how Dulera would be able to gain market traction with Advair (and, to a lesser extent, Symbicort) having the lion's share of the market, even in light of Teva and Sandoz forgoing attempts to produce generic versions of Advair for the time being.

Despite the cool European brand name, Dulera sounds like Asmanex + LABA - the once daily selling point of Asmanex.

Disclaimer: long-term asthma patient who's used both Advair and Asmanex, and gets great asthma control using one puff of Advair 100/50 daily.