The FDA grants full approval to Pfizer’s Covid antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus.
Paxlovid is specifically advised for the treatment of mild to moderate Covid in adults older than 50 and people who suffer fromThat includes those who have diabetes, heart conditions, cancer or a weak immune system.The FDA first made Paxlovid available in December 2021 under emergency use authorization for high-risk individuals ages 12 and up. Under that designation, the FDA quickly approved the treatment based on preliminary clinical trial data.
Both Pfizer and the FDA view the treatment as an important complementary tool to vaccination that can help high-risk Americans manage their Covid infections and ultimately save lives. That means Pfizer will sell Paxlovid directly to healthcare providers at a price the company hasn’t disclosed. Paxlovid is priced at about $530 per course now.In March, an independent panel of advisors to the FDAOne trial examined high-risk adults who were unvaccinated and had no prior Covid infection.
The FDA said the most common drugs that caused safety issues were immunosuppressants, which are often used to treat HIV and organ transplant patients.
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