CytRx Corp. is a biopharmaceutical research and development company focused on the development of high-value human therapeutics. Its current development pipeline includes programs in clinical development for cancer indications, including its lead drug candidate tamibarotene, for the treatment of acute promyelocytic leukemia (APL).
The company today announced that tamibarotene has received an official positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency. The opinion now sits before the European Union (EU) commission for final approval and publication in the community register.
The company has already secured Orphan Drug Designation for APL and Fast Track Designation of tamibarotene by the U.S. Food and Drug Administration (FDA) in October of 2007. Steven A. Kriegsman, CytRx president and CEO, said COMPâ€™s review and opinion of the drug candidate validates tamibaroteneâ€™s value in the marketplace.
“We believe that the positive opinion by the COMP reflects the potential therapeutic value of tamibarotene as a treatment for European patients suffering from APL, especially for those who currently lack an effective third-line therapy for their disease. We consider this positive opinion important as it supports our ability to pursue marketing approval for tamibarotene in the EU in addition to our ongoing U.S. clinical program,” Kriegsman stated in the press release.
According to the company, the positive opinion will allow it to move forward with EU regulations and puts it one step closer to gaining EU marketing approval.
â€œThe granting of orphan medicinal product status for tamibarotene will provide us with an improved communications mechanism with the European Medicines Agency (EMEA) and other EU regulatory officials going forward as we pursue EU approval. Added interaction between the EMEA and CytRx during the regulatory process could assist us in obtaining marketing approval for tamibarotene for the treatment of APL in the EU,â€ CytRx chief scientific officer Jack Barber, Ph.D., stated in the press release.
Similar to the FDAâ€™s orphan drug grants, the European Commission grants orphan medicinal product status for drugs used to prevent or diagnose diseases or conditions. The European Commission grants such approval to promote innovation in the development of treatments for diseases that affect no more than five in 10,000 persons in the EU.
If CytRx is successful in getting orphan drug grant from the commission, the company will have exclusive marketing rights of tamibarotene in the EU for 10 years, as long as it also gets marketing approval.