US FDA extends review of KalVista’s swelling disorder drug due to heavy workload

By Puyaan Singh

(Reuters) -KalVista Pharmaceuticals’ said on Friday that the U.S. Food and Drug Administration had extended the review of its drug for a type of hereditary swelling disorder due to heavy workload and limited resources.

The FDA indicated that it now expects to deliver a decision within four weeks, KalVista said.

The original target action date for the decision on the medication, named sebetralstat, was set for June 17 by the regulator.

The extension is the latest instance of the FDA missing a deadline following mass layoffs as part of a major overhaul of federal health agencies under U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.

KalVista said the FDA had not requested additional data or studies and had not raised any concerns regarding the safety, efficacy or approvability of the drug.

"We remain confident in the potential for near-term approval of sebetralstat," the company told Reuters in an email.

It also said it had addressed all prior information requests in a timely manner and believed the only remaining item under FDA review was the finalization of the packaging insert.

If approved, sebetralstat will become the first on-demand oral treatment for hereditary angioedema, offering a convenient alternative to injectable treatments.

The life-threatening condition causes sudden, dangerous swelling in the body, including the skin, digestive tract and upper respiratory system, due to deficiency in a protein known as C1 inhibitor.

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