Flexion’s Slow-Release Steroid Now On Faster Track With FDA
This article was originally published in The Pink Sheet Daily
Following guidance from the agency on injectable osteoarthritis drug FX006, Flexion plans to file first with single-dose studies instead of waiting for longer-term data for repeated doses. This will speed up initial Phase III work by one year, the firm says.
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Now focused on two key programs in its osteoarthritis portfolio, the Massachusetts drug developer will align itself for a more traditional exit rather than a Big Pharma partnership.
Modeled on Lilly's Chorus unit, Flexion purports to bring candidates to proof-of-concept quicker and cheaper than a Big Pharma typically can.
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.