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news.SkyePharma has announced FDA clearance for review of New Drug Application (NDA) for Lodotra, submitted by its licensee, Horizon Pharma.
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Lodotra, used in the treatment of rheumatoid arthritis (RA), is a programmed-release formulation of low dose prednisone, that is developed using SkyePharma’s Geoclock technology in collaboration with Horizon.
The FDA-approved Prednisone is used to inhibit the production of various pro-inflammatory cytokines, the proteins associated with joint inflammation in RA.
According to the company, the FDA has set a Prescription Drug User Fee Act (PDUFA) date, when the review is scheduled to be completed, of 26th July 2012 based on the standard 10 month review, the company said.
Lodotra is currently approved for marketing in 16 European countries.
SkyePharma CEO Axel Müller said their Geomatrix and Geoclock technologies enable controlled- or timed-release versions of immediate-release products to be developed, benefiting both partner companies and patients.