FDA to review Merck Covid pill next week

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FDA to review Merck Covid pill next week

Federal health regulators say an experimental Covid 19 pill from Merck is effective against the disease, but they will seek input from outside experts on risks of birth defects and other potential problems in pregnant women.

The Food and Drug Administration will hold a public meeting next week where academic and other experts will weigh in on the safety and effectiveness of the pill. The agency isn't required to follow the advice of the group.

The FDA scientists said that they identified several potential risks, including possible toxicity and birth defects. Regulators also noted that Merck collected less safety data on its drug than was collected for other Covid therapies.

All Covid drugs that are currently authorized by the FDA require an injection or IV, which limits their use. If approved, Merck's medication would be the first patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K.

With cases rising in most of the U.S., regulators are expected to approve Merck's drug as an important new weapon to help relieve the strain on hospitals. The FDA review is the key to determining who will be eligible and how widely it might be prescribed.

The FDA will ask its independent advisers if the drug's benefits outweigh its risks and if it should be restricted for pregnant women.