Participation in the Pilot 2 program is limited to no more than one fast track product for each review division within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Squalamine is the product selected by CDER’s Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products.
Squalamine is a systemically administered anti-angiogenic small molecule. Genaera is currently conducting three phase II trials of squalamine in age-related macular degeneration (AMD) at multiple sites throughout the US.
The continuous marketing application (CMA) Pilot 2 program provides for frequent scientific feedback and interactions during the investigational new drug (IND) phase of new drug development based on a defined agreement between the FDA and the applicant. The FDA initiated the CMA Pilot 2 program to evaluate the costs and benefits of increased sponsor access to guidance and feedback from the FDA for fast track products.
“We are honored that squalamine has been accepted into this pilot program and look forward to frequent collaborative interactions and dialogue with the Agency in the development of squalamine,” commented Dr Roy Levitt, president and CEO of Genaera.
“Inclusion in this FDA initiative recognizes the serious unmet medical need of patients with AMD and the potential value of enhanced interactions and dialogue with the Agency to potentially facilitate timely and efficient development of squalamine as a promising novel therapy for AMD.”
Genaera anticipates being able to report early data from the first phase II trials starting early in 2005 and intends to begin phase III trials in the first half of 2005 to run concurrently with the company’s largest phase II trial.