NeoPharm, Inc. announced that its IL13-PE38QQR development programme has been accepted for inclusion in the US Food & Drug Administration's (FDA) new Continuous Marketing Application (CMA) Pilot 2 programme. NeoPharm will work with the FDA over the next several weeks to finalize an agreement on NeoPharm's participation in the programme. The objective for this exploratory programme is to test the CMA concept during the Investigational New Drug (IND) phase of new drug and biological product development to determine whether such activity can improve the efficiency of the drug development and review process and shorten review time.
Under the CMA Pilot 2 program, the FDA and Fast Track drug applicants enter into an agreement to engage in frequent scientific feedback and interactions during the IND phase of product development. According to FDA guidelines, the CMA Pilot 2 programme will evaluate the cost of such enhanced interaction between the FDA and applicants and whether it improves the efficiency and effectiveness of development programmes, and will be limited to no more than one Fast Track product for each of 20 participating FDA review divisions.
"We are happy to have been selected to participate in the new FDA CMA Pilot 2 Programme," said James Hussey, NeoPharm's CEO. "We are committed to work closely with the FDA throughout the entire IL13-PE38QQR drug development process, from trial design, clinical drug supply, ongoing clinical trials, data presentation, through, ultimately, application for FDA approval for commercial use of IL13-PE38QQR in treating recurrent glioblastoma multiforme," Hussey said.
CMA Pilot 2 applications are evaluated based on FDA's overall assessment of the potential value of enhanced interaction, emphasizing the potential public health benefit resulting from development of the product, the likelihood that concentrated scientific dialogue will facilitate the availability of a promising novel therapy, and the applicant's demonstration of commitment to product development as evidenced by a thorough consideration of the rationale for participation in CMA Pilot 2.