Discovery Labs: Surfaxin approval unlikely

Following an end of review meeting with the FDA, Discovery Labs said yesterday that it is unlikely that its lung drug Surfaxin will gain the agency's approval anytime soon. The company was dealt a blow in April when the FDA rejected it's application for the drug, saying that certain aspects of a Surfaxin biological activity test (a quality control stability and release test) had to be resolved before the Surfaxin can win approval. The drug is intended to treat premature infants with Respiratory Distress Syndrome.

At a follow-up meeting in early June, the FDA said it was applying a newly-defined standard to determine whether Discovery Labs had adequately demonstrated comparability of Surfaxin to commercial drug product. In a statement, the company said the FDA's new standard represents a "significant hurdle" in their quest for Surfaxin's approval, adding that it is unlikely that Discovery will be able to satisfy this requirement with existing preclinical comparability data. That virtually ends the drug's chances of near-term approval.

Discovery may appeal the FDA's decision, but in the meantime it will focus on two pipeline programs--Surfaxin LS and Aerosurf. According to the company's CEO Robert Capetola, the issues raised by the FDA regarding Surfaxin do not apply to the company's other programs.

- here's Discovery's release [1]
- see the Reuters report [2]

Related Articles:
FDA rejects Discovery Labs' Surfaxin [3]
Discovery Labs shares dive on FDA delay [4]
Discovery secures $60M financing deal [5]
Battered Discovery Labs tries to reassure investors [6]
FDA delays Discovery Labs approval [7]