Drugs

United Therapeutics NDA Review Extension for Tyvaso

FDA has extended its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil), indicated for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, after receiving an information request letter from the agency. According to the company, FDA requested additional information on the pulmonary safety of Tyvaso DPI related to a pending citizens petition. United Therapeutics says it has responded to the agency’s request, but the agency determined this to be a major amendment to the NDA. The new user fee review action deadline is in May.

This is the latest setback on getting the NDA approved. In October, FDA issued a complete response letter on the submission that cited a deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the drug substance. Additionally, the letter said the agency has not yet completed its review of a citizen petition submitted by Lassman Law+Policy on behalf of an unnamed client in July concerning the safety of an excipient in Tyvaso DPI.

The petition says specific additional testing is necessary because a primary component of the Tyvaso formulation is fumaryl diketopiperazine, a novel excipient previously approved for use only in manufacturing partner Mannkind’s Afrezza (insulin recombinant human) inhalation powder. “Afrezza, however, poses a serious risk of acute bronchospasm in patients with chronic lung disease, such as asthma and chronic obstructive pulmonary disease,” the petition said (see earier story).

Tyvaso is formulated with MannKind’s dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza (insulin human) Inhalation Powder, which was approved in 2014. The companies say they are also developing BluHale, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use.

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

Read more

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