FDA Declines Basilea Superbug Drug Application

Boston (DbTechNo) – The FDA (Food and Drug Administration) have declined the approval application of Basilea for their experimental superbug antibiotic.

This is not the first time the FDA has done this, as last year they also declined the approval application of the company’s experimental superbug drug.

Shares in the Swiss drug maker plummited upon news of the FDA decision, falling by more than 20 percent.

The drug maker was seeking to have their antibiotic, ceftobiprole approved for use in America to treat people diagnosed with MRSA infections.

The agency sited 2 key studies that according to them, can not be relied on because of shaky monitoring by the study sponsors, Johnson and Johnson.

MRSA infections are appearing more and more in hospitals, a bad sign for sure because they are resistant to many types of antibiotics that used to work in treating them.

They also are being diagnosed more and more in the community, in places such as schools, and long term care facilities.

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