Drugs

Petition Asks FDA to Reject Tyvaso Without Specific Info

A 7/8 petition submitted by an unidentified party is asking FDA to refuse to approve the NDA for United Therapeutics’ Tyvaso DPI, a dry powder inhalation formulation of treprostinil in the absence of additional clinical data demonstrating that it is safe for use in patients with certain chronic lung diseases and compromised pulmonary function. The petition says specific additional testing is necessary because a primary component of the Tyvaso formulation is fumaryl diketopiperazine (FDKP), a novel excipient previously approved for use only in 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 says. “FDA reviewers have suggested that FDKP, which is an irritant, is responsible (at least in part) for the acute bronchospasm observed in the Afrezza clinical trials. As a result, Afrezza’s approved labeling carries a prominent Boxed Warning alerting healthcare providers that Afrezza is contraindicated in patients with chronic lung disease and requires pre-treatment testing to identify potential lung disease in all patients.”

The petition asks that FDA:

refuse to approve the Tyvaso DPI NDA in the absence of additional clinical data from one or more adequate trials demonstrating that FDKP at the levels used in Tyvaso DPI dry powder formulation is safe and does not present undue risks of acute bronchospasm in the intended patient populations;
require Tyvaso DPI be contraindicated in patients with chronic lung disease;
require the Tyvaso DPI labeling to contain a conspicuous Boxed Warning about the risk of acute bronchospasm and the need to conduct rigorous testing before starting Tyvaso to identify comorbid chronic lung diseases; and
refuse to approve Tyvaso DPI without a Risk Evaluation and Mitigation Strategy intended to educate healthcare professionals about the risk of acute bronchospasm in patients with chronic lung disease and the need to conduct testing before starting Tyvaso treatment.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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