FDA adds another drug OK to cap a record win list for 2021

Friday, December 31, 2021

Source: Endpoints News

With the clock ticking through the final hours of an eventful 2021, FDA regulators took the opportunity to squeeze in one more drug approval.

This time the nod went to Xeris for a rare disease treatment known as levoketoconazole, now approved for sale as Recorlev. The drug is designed to treat hypercortisolemia in patients suffering from Cushing’s syndrome. In late stage studies, researchers tracked a drop and normalization in cortisol levels in patients.

It marks the 61st new drug approval at the FDA – adding to a slate of biologics OKs with 51 in the win column at CDER. That’s a record, just barely topping the track record of the past few years – though also playing out during a global pandemic that interfered with a number of routine inspections needed for approvals.


Recorlev maintained a relatively low profile in its travel through the pipeline. Xeris picked it up in a small $267 million buyout of Strongbridge, the latest biotech to be helmed by the longtime vet John Johnson. The deal was completed just weeks ago, with Xeris CEO Paul Edick leading the charge.

Xeris shares $XERS jumped 25% Friday morning, lifting the microcap past the $300 million mark.

“Cushing’s syndrome is a rare disease that can be physically and emotionally devastating to the patient. Most patients endure years of symptoms prior to obtaining a diagnosis and are then faced with limited effective treatment options,” said Leslie Edwin, president of the Cushing’s Support & Research Foundation.

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