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European Commission grants orphan drug designation to GenSight’s retinitis pigmentosa treatment
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GenSight Biologics announced the European Commission granted orphan drug designation to product candidate GS030 for the treatment of retinitis pigmentosa.
The commission granted the designation based on a favorable recommendation from the European Medicines Agency. The EMA also granted advanced therapy medicinal product classification to GS030, according to a company press release.
The orphan drug designation provides GenSight with incentives and benefits in the European Union, including a period of market exclusivity if GS030 is approved for the treatment of retinitis pigmentosa. The commission grants orphan drug designation to provide incentives to develop medicinal products for diseases and conditions that affect no more than five in 10,000 persons in the EU.
GS030 is undergoing preclinical development and is expected to initiate a good laboratory practices regularity toxicity study in non-human primates this month. A phase 1/2 clinical trial in retinitis pigmentosa patients is planned for the third quarter of 2017.