August 8, 2018 / 6:08 PM / a year ago

UPDATE 1-U.S. FDA panel backs approval of Paratek's antibiotic

(Adds details from panel meeting, background)

By Manas Mishra

Aug 8 (Reuters) - A U.S. Food and Drug Administration expert panel on Wednesday voted in favor of approval of Paratek Pharmaceuticals Inc's antibiotic to treat bacterial pneumonia and skin infections.

The panel voted 17-1 in favor of the drug's safety and effectiveness in treating acute bacterial skin and skin structure infections, and voted 14-4 for treating community acquired bacterial pneumonia.

The vote comes ahead of a final decision by the FDA on the drug's approval, which is expected by early October. The FDA typically follows the recommendations of its advisory panels, but is not obliged to do so.

The panel reviewed three late-stage trials, and majority of the discussion revolved around the high number of deaths in pneumonia patients who took Paratek's drug, omadacycline, compared to patients taking another antibiotic in one of the trials.

In the 774-patient trial, there were twelve deaths - eight among those who were administered omadacycline and four in the moxifloxacin arm.

Some panel members suggested post-marketing follow up be done by the company to tackle the issues.

"The reality is, we are going to see deaths with really sick people. It is comforting to me that the drug is safe and effective within the parameters that we look at normally for infectious disease products," said Peter Weina, colonel, medical corps, U.S. army, who was part of the FDA panel.

Omadacycline would be the first of a new class of antibiotics known as aminomethylcyclines, and could help in countering growing antibiotic resistance.

With a number of infections becoming harder to treat as older antibiotics become less effective, there is a push by regulators to get newer ones into the market.

If approved, Omadacycline would be the company's first product to reach the market.

Guggenheim analysts have forecast sales of $343 million for the drug in treating pneumonia, and $192 million as a treatment for skin infections in 2025. (Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)

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