SPARC gets orphan drug designation from USFDA for novel kinase inhibitor

NEW DELHI, July 8: Sun Pharma Advanced Research Company Monday said the US health regulator has given orphan drug designation to its novel kinase inhibitor, SCO-088, for the treatment of chronic myeloid leukemia (CML). The Orphan Drug Act provides economic incentives to encourage the development of drugs for diseases affecting fewer than 2 lakh people in the US, Sun Pharma Advanced Research Company (SPARC) said in a filing to BSE.

“This is an important milestone in SPARC’s journey to provide solution for patients who are not responding to the existing treatments available in the market. SCO-088 will fill the gap in the treatment of resistant CML,” SPARC CEO Anil Raghavan said.

Orphan drug designation will grant seven years of US market exclusivity upon approval of SCO-088 for the treatment of patients with CML, SPARC said.

Incentives include waiver of user fee by United States Food and Drug Adminstration (USFDA) and assistance in clinical trial design by the regulator, it added.

Shares of SPARC were trading at Rs 113.80 per scrip on BSE, down 2.94 per cent from the previous close. (PTI)


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