Fresenius Kabi gets approval for drug used in COVID-19 treatment

Fresenius Kabi said it is making a sedation drug used in the treatment of COVID-19 patients available in the U.S. after gaining Emergency Use Authorization from the U.S. Food and Drug Administration.

Fresenius Kabi Propoven 2% provides sedation via a continuous infusion in patients 16 years or older who require mechanical ventilation in an intensive care unit, according to the German pharmaceutical company, which has its North American headquarters in Lake Zurich.

While the drug is not formally approved in the U.S., it has been available since 2000 and is approved in 58 countries, the company said in a statement Monday. Propoven 2% contains the same active ingredient, propofol, as Fresenius Kabi's FDA-approved Diprivan, but contains double the concentration.

“Since the beginning of this pandemic, Fresenius Kabi has taken many steps to prioritize the production of products that are essential in helping to treat COVID-19,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are grateful to the FDA for providing this Emergency Use Authorization for Propoven 2% as another solution to help severely ill patients during this public health crisis.”

Seema Kumbhat, M.D., senior vice president and regional medical director at Fresenius Kabi USA, noted the company will also provide information about the product's differences from Diprivan 1%, since Propoven is not a familiar product among U.S. clinicians.

“A higher concentration presentation of propofol could be helpful to providers managing COVID-19 patients who require mechanical ventilation,” she said.

The company will manage the distribution of Propoven 2% through direct shipments and provide additional product-related materials, including alert stickers to place directly on the vial, wall charts to display for use in areas such as hospital pharmacies and ICUs, a health care provider fact sheet and a patient and caregiver fact sheet.