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Rapid review for Pfizer’s superbug vaccine

FDA to expedite assessment of Clostridium difficile inoculation
FDA headquarters White Oak

US regulators will expedite the review process for Pfizer's vaccine to prevent the hospital superbug Clostridium difficile.

The FDA yesterday granted Fast Track status to PF-06425090, which is in phase II trials to prevent a disease that is estimated to lead to 14,000 deaths each year in the US, according to the Centers for Disease Control and Prevention.

Fast Track reviews speed up the assessment process and are reserved for new medicines that can treat or prevent serious conditions where there is an unmet medical need.

This is certainly true in the case of C. difficile, which is the most common bacterial infection that patients pick up in hospitals or long-term care facilities and can lead to life-threatening diarrhoea and inflammation of the colon.

Treatment options for C. difficile are limited and include the antibiotics metronidazole, butvancomycin and fidaxomicin and, in serious cases, a faecal transplantation.

Resistance to antibiotics is a major global health concern, however, and the introduction of a vaccine would be a much-needed preventative measure against C. difficile.

Sanofi is also developing a vaccine to prevent C. difficile and is in the middle of a phase III research programme called Cdiffense. The French company published data in May this year that demonstrated the candidate vaccine generated an immune response against C. difficile toxins A and B.

Paediatric indication for Elelyso

Pfizer received additional positive news from the FDA with the regulator's decision to approve a paediatric indication for Gaucher disease treatment Elelyso (taliglucerase alfa).

The drug was already available as a long-term enzyme replacement therapy (ERT) for adults with the genetic disorder type 1 Gaucher disease but it can now be used in children as young as four.

Paige Kaplan of the Children's Hospital of Philadelphia commented: “While type 1 Gaucher disease can manifest in childhood or adulthood, the disease more often presents during childhood. It is important that children with this disease have access to a range of FDA-approved treatment options that are effective.”

29th August 2014

From: Sales, Healthcare



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