SPARC Receives Orphan Drug Designation from the USFDA for SCO-088 for the Treatment of Chronic Myeloid Leukemia Patients
MUMBAI : Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that the U.S. Food and Drug Administration (USFDA) has granted Orphan Drug Designation to SCO-088 for the treatment of patients with Chronic Myeloid Leukemia (CML).
“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” said Anil Raghavan, CEO of SPARC.
The Orphan Drug Act provides economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan Drug Designation will grant seven years of US market exclusivity upon approval of SCO-088 for the treatment of patients with CML. Incentives include waiver of user fee by USFDA and assistance in clinical trial design byUSFDA.