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Following submission of new drug application of Zilretta (FX006) for knee osteoarthritis in mid-December 2016, Flexion Therapeutics CEO Mike Clayman is hoping for priority review of the filing, in addition to fast track status. Zilretta is an extended release formulation of the triamcinolone acetonide. Steroid injection is a common treatment, but pain relief wanes after two to four weeks. Competing against generic steroids, which cost only USD 10–20 per dose, presents a big commercial challenge however. In an interview at Biotech Showcase, Clayman explains the rationale for pricing a long-acting steroid at USD 500 per dose and the company's commercial strategy.
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Scrip: industry news and insights
The Swiss major's pharma chief tells Scrip that its gene therapy for SMA offers much more than Biogen's Spinraza for both patients and payers, noting that the company is ready with alternative payment models for the pricey treatment as soon as approvals for Zolgensma are granted.
Topics Business strategies Drug approval Drug development landscape Drug review
Scrip: industry news and insights
By Emily Hayes
In second Phase III diabetes study to report, oral GLP-1 agonist semaglutide misses some weight loss goals when compared with Boehringer/Lilly's SGLT-2 inhibitor Jardiance.
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