Pfizer Covid Pill Seeks FDA Approval

 

Soon you may be able to treat Covid-19 as easily as you would a urinary tract infection. Pfizer pharmaceutical has asked the FDA to authorize their easy-to-use pill for home treatment in high-risk patients.

Other options for Covid treatment have mostly required hospitalization. Gilead Sciences, Inc. produced the antiviral drug remdesivir, but it requires parenteral treatment which means hospitalization. Monoclonal antibodies have proven effective but are costly and typically given in doctors’ offices or hospitals.

Jared S. Hopkins, writing in The Wall Street Journal, says clearance from the FDA would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease. “There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bouria said. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”

The Pfizer drug is called paxlovid. President Biden has said the U.S. has secured supply of the Pfizer drug. A person familiar with the matter said the U.S. was working on a contract for 10 million courses of treatment. Pfizer projects it will manufacture more than 180,000 courses of treatment this year, and plans to increase production to at least 50 million courses next year.

Paxlovid reduced the risk of hospitalization or death in high-risk people in a late-stage study with mild to moderate Covid-19 by about 89% if they took the pill within three days of diagnosis, according to Pfizer. Researchers reported paxlovid was found to be generally safe and well-tolerated. Paxlovid was performing so well in the trial that Pfizer said it stopped enrolling subjects after discussions with the FDA. Drug makers typically stop studies, after discussion with health regulators, if an experimental drug is found to be so effective that it would be unethical to continue the study including subjects who received a placebo.

If approved, the drug could be taken at home shortly after they first develop Covid-19 symptoms. A course of treatment consists of 30 ills over five days. Twice a day, patients would take two pills of paxlovid and one pill of another antiviral called ritonavir.

This comes on the heels of earlier reports that Merck and Ridgeback Biotherapeutics have produced their own Covid pill call molnupiravir. (see Covid Pill Should be Coming Soon) With these companies applying for FDA approval of outpatient oral treatments for Covid, the future looks much brighter. Merck is still waiting for FDA approval, however. Merck has also licensed out production of molnupiravir to generic drugmakers in India.

Paxlovid works differently from the Merck-Ridgeback pill and presents fewer safety concerns, according to some physicians and scientists. Researchers designed the Pfizer pill to stop the coronavirus from spreading in people by blocking activity of a key enzyme, known as protease, that the virus needs to replicate. Drugs blocking protease have proven effective in treatment of other viruses, like HIV, which causes AIDS.

The FDA has shown reluctance to approve the Merck-Ridgeback pill without Phase 3 trials.  It remains to be seen if this will be an impediment to approval of the Pfizer pill.

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