FDA accepts app for Merck, Sanofi 6-in-1 combo vaccine

Gary Marshall--Courtesy of University of Louisville School of Medicine

Sanofi's ($SNY) Pentacel, which protects children against 5 serious diseases, nabbed the No. 3 spot on the world's list of best-selling vaccines last year. Whether an investigational 6-in-1 combo from the French drugmaker and partner Merck ($MRK) can eventually match its success remains to be seen, but the pair is now one step closer to finding out.

The FDA Monday accepted a Biologics License Application for the hexavalent prospect, DTaP5-IPV-Hib-HepB1, which protects against diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), and invasive disease caused by Haemophilus influenzae type b (Hib)--the same diseases Pentacel fends off--plus hepatitis B. The agency's decision deadline is undisclosed, and the application will undergo a standard 12-month review from its August filing date, a Merck spokeswoman told FierceVaccines.

University of Louisville School of Medicine professor Gary Marshall, who led the Phase III trial of the prospect, called results of that 1,400-infant trial encouraging, with the candidate showing similar immune responses against the antigens covered by Pentacel plus Merck's hep B vaccine Recombivax.

Sanofi Pasteur SVP of R&D John Shiver

Vaccines generally need to score key recommendations--as well as FDA approval--to see widespread uptake in the U.S. But as John Shiver, Sanofi Pasteur's SVP of R&D, pointed out in a statement, leading organizations--like the CDC's Advisory Committee on Immunization Practices (ACIP)--tend to smile on "the use of combination vaccines instead of individual injections."

If DTaP5-IPV-Hib-HepB1 can come anywhere close to Pentacel's sales, it'll be in good shape. Sanofi's blockbuster brought in $1.53 billion in worldwide sales last year, and EvaluatePharma predicts that haul will increase to $2.34 billion by 2020.

- read the release

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