Drugs

Smallpox Drug Development Guidance

FDA has issued a draft guidance, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention, to assist sponsors in clinical development of drugs for treating or preventing smallpox infection. “Clinical efficacy trials of drugs for the treatment or prevention of smallpox are not feasible,” the document says, “and challenge studies in healthy subjects are unethical; therefore, drugs for these indications should be developed and approved under the regulations commonly referred to as the ‘animal rule.’” The draft says it is intended to serve as a focus for continued discussions among the CDER Division of Antiviral Products, drug sponsors, the academic community, and the public.

The guidance focuses on drugs that are expected to act by inhibiting variola virus replication. Although the document’s primary focus is on antiviral drugs, therapeutic proteins or monoclonal antibodies also may be eligible for evaluation under the animal rule. “Sponsors interested in developing small molecules, therapeutic proteins, or monoclonal antibodies for use against smallpox are encouraged to discuss their approach with FDA as early as possible in development and are encouraged to communicate with FDA through the pre-IND Consultation Program,” the agency says.

The guidance does not address treatment of bacterial complications of smallpox or development of biological therapies such as vaccines or antisera to treat or prevent smallpox. It also does not discuss the general issues of statistical analysis or clinical trial design.

The draft revises an 11/2007 draft with modifications pertaining to key study design considerations for animal efficacy studies; selection of an effective dose in humans; nonclinical virology issues; key pharmacology and toxicology issues; and chemistry, manufacturing, and controls for drugs developed for smallpox. FDA says the revisions are intended to streamline the guidance and incorporate input from a 2009 public workshop and a 2011 advisory committee meeting.

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