Thursday, June 24, 2010

FDA Approves Dulera®; NOT Likely To Cause Any Lasting Stock Price Increase. Why?

Merck just received FDA approval for Dulera® this morning. However, Dulera is essentially Nasonex® [essentially mometasone furoate, depicted at right -- click to enlarge], mixed as a fixed-dose combination, with the main active ingredient in Foradil®. That is to say, Dulera contains a long acting beta2-adrenergic agonist, or a LABA, for short. Quite rightly, based on recent monitoring, and adverse event reports, FDA has stepped up the black box warnings on that class of drugs. Here is part of the Dulera warning FDA mandated, as part of the approval:

. . . .long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in Dulera®, INCREASE the risk of asthma-related DEATH.

Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Therefore, when treating patients with asthma, Dulera should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. . . .

Dulera is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Dulera is contraindicated in patients with known hypersensitivity to any of the ingredients in Dulera.

Dulera is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms. Increasing use of inhaled, short-acting beta2-agonists is a marker for deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen. . . .

Thus this drug is really only appropriate for a very small portion of the asthma population -- the most severely ill. And so, in my opinion, Dulera enters a crowded field, with a black box warning, and (at best) will "cannibalize" the legacy Schering-Plough drug branded as Foradil®.


Anonymous said...

This will eventually join the ranks with Advair for use in COPD.

Lots of Dr still write scrips for these combo drugs for asthma.

Though, it is a 'me-too' (albeit a very late one) and will probably only grab a small slice of the overall market.

I guess better late than never but, this one was on the development path a long, long time.

Anonymous said...

Dulera is entering a $5.6 billion dollar fixed dose combination market in the U.S. that is growing 8-9% per year and will compete with Advair and Symbicort. It is not a "me-too" and can nicely round out Merck's broad respiratory portfolio.