Drugs

FDA Delays Review Action on Liquidia NDA

FDA has told Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the company’s NDA for Yutrepia (treprostinil) inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The agency explained that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA, according to Liquidia, adding that it has not received any requests for additional clinical data to support the submission.

“We are in active communication with the FDA regarding the process we followed to amend our NDA to add PH-ILD to the labeled indication,” the company says. “Whether the NDA is amended or supplemented, we will continue to prepare for the final FDA approval of Yutrepia to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for [United Therapeutics Corp.’s] Tyvaso on 3/31. “As communicated by the tentative approval to treat PAH, Yutrepia has already met the regulatory standards for quality, safety and efficacy.”

Liquidia notes that FDA 11/5/2021 issued a tentative approval for Yutrepia for treating PAH to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. And last July, the company filed an amendment to the NDA that sought to add PH-ILD to the label. “The FDA previously confirmed that Yutrepia may include the treatment of PH-ILD to the proposed label for Yutrepia without additional clinical studies,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome