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Liquidia (LQDA) PAH Drug Gets FDA's Complete Response Letter

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Liquidia Technologies, a subsidiary of Liquidia Corporation (LQDA - Free Report) announced that the FDA has issued a complete response letter to its new drug application seeking approval of LIQ861.

LIQ861 is a dry powder inhalation formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH). The CRL stated that the FDA cannot approve the NDA in its present form and additional information is required on chemistry, manufacturing and controls (CMC) data related to the drug product and device biocompatibility.

The FDA also said that due to travel restrictions amid the COVID-19 pandemic, it was also not able to conduct a pre-approval inspection (PAIs) of two of Liquidia’s U.S. manufacturing facilities required before approving the NDA. However, the CRL did not state that Liquidia would need to conduct any additional study

Liquidia believes LIQ861 can overcome the limitations of current inhaled therapies and it can safely deliver higher doses into the lungs, thereby offering increased benefits of treprostinil. The company believes it can resolve the issues raised in the CRL in a timely manner, which will not delay the potential launch of the drug in the second half of 2022.

Shares of Liquidia Corporation were down 5.2% on Wednesday in response to the CRL. Liquidia’s stock has declined 31.2% this year so far compared with a decrease of 1.5% for the industry.

 

 

Treprostinil is the active pharmaceutical ingredient in three of United Therapeutics (UTHR - Free Report) PAH medicines namely Remodulin, an injectable formulation of treprostinil; Orenitram, an oral version of treprostinil and Tyvaso, an inhaled version of treprostinil.

Liquidia Technologies and United Therapeutics are involved in patent infringement lawsuit for treprostinil. In March 2020, Liquidia filed two petitions for inter partes review seeking to invalidate two patents on Tyvaso, the '901 and '066 patents. In June, United Therapeutics filed a lawsuit in the district court of Delaware against Liquidia Technologies for infringement of the two patents. Both the patents, related to a method of making treprostinil, expire in December 2028.

United Therapeutics filed the lawsuit within 45 days of receiving notice of filing the NDA by Liquidia. The company claims, under the Hatch-Waxman Act, that the FDA is automatically precluded from approving Liquidia's NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. In July, Liquidia responded to the filing asserting that the patents were not valid and would not be infringed by sales of LIQ861.

In October, the PTAB declined to institute IPR proceedings on the ’066 patent while instituting IPR proceedings on the ‘901 patent. PTAB will issue a final written decision regarding the ’901 patent IP next year.

Liquidia filed the NDA in January 2020, which was accepted by the FDA in April.

Other drugs marketed to treat PAH are Gilead’s (GILD - Free Report) Letairis and J&J’s (JNJ - Free Report) Tracleer and Uptravi. Meanwhile, generic versions ofLetairis and Tracleer have also been launched.

Liquidia currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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