On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by Novartis, Afinitor Disperz is a new dosage form of the existing anti-cancer drug Afinitor. While approved by the FDA in November 2010, Afinitor was for use only in patients three years of age and older. With this new approval, Afinitor Disperz is recommended for use by patients ages 1 and older. This approval is significant in that Afinitor Disperz is the first pediatric-specific treatment aimed at treating these particular tumors.
Both Afinitor and the newly-approved Afinitor Disperz were both approved through the FDA’s Accelerated Approval Program. Through the Program, drug sponsors are able to obtain expedited approval of drug products that are intended to treat serious diseases in situations where there is an unmet medical need. Though this process is accelerated, drug sponsors are still required to perform studies to confirm that the drug product provides the anticipated clinical benefit. In addition, drug sponsors may be required to perform ongoing studies in order to ensure the long-term safety of drugs approved through this process. In fact, both Afinitor and Afinitor Disperz are subject to these ongoing studies. More information about the FDA’s Accelerated Approval Program may be accessed here.
This week has marked a number of firsts with respect to drug approvals. As we recently reported, on August 27, 2012, the FDA approved a new four-in-one combination pill for the treatment of the HIV-1 infection in adults who have not previously received treatment for the infection. For more information about the FDA approval process or the laws and regulations enforced by the FDA generally, please contact us at contact@sglawfl.com.