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FDA OKs Gilead’s Bid to Drop Extended Monopoly on Virus Drug (1)

March 25, 2020, 5:48 PMUpdated: March 25, 2020, 8:13 PM

The FDA granted Gilead’s request to drop extended monopoly rights on potential Covid-19 treatment remdesivir, an agency spokesman said.

Dropping that special status, known as an orphan drug designation, means Gilead Sciences Inc. will waive an extra seven years of exclusivity for the medication. Orphan drug designations are intended to spur companies to develop treatments for rare conditions affecting 200,000 people or less that wouldn’t be economical otherwise.

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” the company said Wednesday afternoon in a statement. “Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.”

Food and Drug Administration spokesman Michael Felberbaum said later that day the agency had withdrawn the rare drug designation for remdesivir. The agency “remains actively engaged with partners across the U.S. government, academia and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus,” he said.

Consumer groups like Public Citizen had criticized Gilead for the designation. Public Citizen, a Washington-based nonprofit, said earlier Wednesday the rare disease status would help Gilead “shut out competitors and charge high monopoly prices.”

Clinical Trials Underway

Affordability and patient access for Covid-19 treatments have been top of mind for public health officials, but so far any legislation that caps prices of potential vaccines or treatments for the disease caused by the new coronavirus have failed.

There’s currently no vaccine or approved treatment for Covid-19, the lung disease caused by the new coronavirus. Remdesivir, which Gilead originally formulated to fight Ebola, is one of a few existing drugs being tested to see if it’s effective against the virus.

Six remdesivir clinical trials are underway around the world, including in China and the U.S. Gilead says it’s also offered several hundred patients in the U.S., Europe, and Japan “emergency access” to the drug. That’s when companies offer unapproved medication to sick patients who have no other approved alternatives to treat their illness.

An influx of individual requests pushed the company this week to announce a transition from accepting individual requests to offering the drug to patients in groups.

(Updated with additional reporting throughout)

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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