Alimera’s Diabetic Macular Edema Drug Iluvien Gets Third FDA Rejection
This article was originally published in The Pink Sheet Daily
FDA cites concerns about safety and manufacturing in third “complete response” letter for intravitreal implant Iluvien in diabetic macular edema. Agency requests new trial and an advisory committee meeting in early 2014.
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Having relatively rapidly built a multi-billion dollar market in wet age-related macular degeneration, biotech and pharma companies may be about to repeat the exercise with diabetic macular edema, a complication of diabetes that’s growing in importance as the population ages and the disease spreads.
FDA has twice rebuffed Alimera’s marketing application for the intravitreal insert, which releases a corticosteroid to treat chronic diabetic macular edema, citing a bad risk/benefit balance. But after meeting with the agency in the second quarter, the company is confident a reanalysis of pivotal data will satisfy the agency.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.