Drug Development

Pfizer racks up an FDA approval for eczema blockbuster hopeful crisaborole

Pfizer will now get a chance to see if the eczema drug crisaborole is really worth up to or beyond $2 billion in annual sales.

The FDA has approved the non-steroidal topical PDE4 inhibitor with anti-inflammatory properties, which Pfizer snapped up last May when it acquired Anacor Pharmaceuticals for $5.2 billion. The drug will be sold as Eucrisa.

The drug came through back in mid-2015 in a pair of studies which enrolled more than 1,500 patients, beating out a placebo and posting an acceptable safety profile.

Pfizer $PFE will have some heavyweight competition in the field of atopic dermatitis. Regeneron and Sanofi have lined up impressive Phase III data for dupilumab, which has helped excite analysts who are projecting a multibillion-dollar peak sales figure for the drug. Some optimistic buy-siders have pushed their peak estimates to $4 billion or $5 billion.

Pfizer has been busily lining up deals after two attempts at a megamerger fell through with AstraZeneca and then Allergan. One of those deals included an $850 million upfront to partner with Merck KGaA on its PD-L1 checkpoint. And the pharma giant willingly paid a hefty premium in closing a deal to buy Medivation for $14 billion earlier this year.

“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis.” said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).


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RAPS Regulatory Convergence 2017