FDA delays Inbrija drug-device combo
- Regulators told Acorda this week they need more time to review the biotech's drug-device combination product for Parkinson's.
- Acorda had expected the decision on Inbrija to come by Oct. 5, but chemistry, manufacturing and controls information that was recently added to the drug's application constituted a "major amendment." As such, it has a new target action date of Jan. 5.
- Inbrija's application can now go one of three ways. The Food and Drug Administration could either OK it by early January; reject it, but for relatively minor problems; or reject it and require Acorda to conduct another clinical study before resubmission.
Thursday's announcement signals an important goalpost for Acorda has moved — and at a time when the biotech needs to score.
Earlier this week, a federal court of appeals effectively cleared the way for generic competition to Ampyra (dalfampridine), a multiple sclerosis drug responsible for pretty much all of Acorda's revenue.
Acorda is thus under immense pressure to find a new revenue stream. On a second quarter earnings call, company executives highlighted the potential of Inbrija (levodopa inhalation powder) to prop up sales.
Regulators are reviewing the drug as a treatment for Parkinson's disease patients experiencing "off" periods, or times when they aren't adequately responding to the standard of care, levodopa. Acorda estimates that 350,000 U.S. patients with the disease have off periods, and that peak U.S. Inbrija sales will be above $800 million.
Having surveyed hundreds of neurologists, primary care physicians and patients, Acorda's market research "continues and reinforces our conviction that off periods represent a large unmet need in the Parkinson's community," CEO Ron Cohen said on the second quarter earnings call in August.
But before Acorda gets its drug to doctors and patients, it must clear some long-standing barriers. For one, Inbrija comes as a drug-device combination, adding another layer of complexity to manufacturing and approval processes.
Jefferies analyst Michael Yee highlighted that a key concern is whether Acorda can demonstrate that patients won't have trouble loading the Inbrija pill into the inhalation device.
In a Sept. 14 statement, Cohen said Acorda is "committed to bringing Inbrija to approval for people with Parkinson's who experience off periods."
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