MedImmune filed a BLA for its next-generation respiratory syncytial virus therapy motavizumab ( Numax ) on Jan. 30, planning the compound as a follow-on to its Synagis (palivizumab), the biotech announced Feb. 4. If accepted by FDA for a standard review, the investigational monoclonal antibody should have an action date of Nov. 30.

A wholly owned subsidiary of AstraZeneca since last June, MedImmune could have filed the BLA in 2007 but decided to wait for data from a second Phase III trial testing the drug in Native American infants (¹ Also see "MedImmune Inks Third Reverse Genetics Licensing Deal For Influenza Vaccines" - Pink Sheet, 24 August, 2007.). That trial showed the drug reduced RSV-related hospitalizations by 83 percent compared with placebo.

The Gaithersburg, Md. firm says it will commercialize motavizumab in the United States through its existing sales and marketing force and co-market the drug in certain markets outside the U.S. with partner Abbott, which holds the product's ex-U.S. marketing and distribution rights.

Motavizumab was tested in an active-controlled Phase III trial against Synagis in roughly 6,600 pediatric patients at high risk for serious RSV-related illness. It met the primary endpoint of noninferiority, reducing incidence of RSV hospitalizations by 26 percent compared with Synagis therapy (² Also see "MedImmune Delays Numax BLA Pending Additional RSV Trial Data" - Pink Sheet, 7 February, 2007.).

The drug also met a secondary endpoint in the two-year, randomized, double-blind trial by reducing incidence of RSV-specific, medically attended outpatient lower respiratory infections by 52 percent.

"Beyond the findings of the various investigational trials for motavizumab, we believe this molecule will help reinforce the positive role that MAbs play in RSV prevention within the current clinical body of evidence," said MedImmune VP-Clinical Development, Infectious Disease Genevieve Losonsky. "It also reinforces our position as a leader in RSV prevention."

RSV, a leading cause of viral respiratory infection among infants, results in an estimated 125,000 U.S. infants being hospitalized each year with severe RSV infections, making it the nation's leading cause of infant hospitalization.

-Joseph Haas (j.haas@elsevier.com)

MedImmune Files BLA For Pediatric RSV Candidate

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