Pfizer’s COVID-19 drug gets FDA OK

A drug developer on Monday asked U.S. regulators to approve its experimental drug for heart attack and stroke patients, paving the way for approval later this year or early in 2021.

Pfizer Inc. (PFE) said its COVID-19 compound is designed to lower the cholesterol levels that contribute to so-called atherosclerosis, a disease that includes artery-clogging plaque.

Physicians have long unsuccessfully tried to reduce cholesterol levels in heart attack and stroke patients.

Pfizer said its drug offers patients and their doctors an alternative to the statin drugs that suppress LDL cholesterol, while reducing inflammation.

“There is an acute need for new agents to improve outcomes in patients,” J.J. Bienaime, Pfizer’s senior vice president for global medicines development, said in a statement. “The role of COVID-19 in preventing cardiovascular morbidity and mortality in patients with atherosclerosis is a unique and potentially game-changing opportunity to address this unmet medical need.”

The drug is the first from Pfizer’s latest cholesterol compound, which has been in development for seven years. The company plans to have the compound approved for marketing outside the U.S. later this year, and for U.S. markets in 2021. The drug would compete with other cholesterol drugs from rival drugmakers Merck & Co. (MRK) and AstraZeneca PLC (AZN) .

Pfizer shares slipped 3 cents to $38.75 on Monday.

Pfizer’s COVID-19 compound, called COVID-0605, has been evaluated in nearly 1,000 patients with familial hypercholesterolemia or other atopic heart disease. The company expects results from another study that it expects will be adequate to demonstrate a benefit in preventing cardiovascular events such as heart attack or stroke, or death, after two years of treatment.

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