FDA Accepts NDA for a Potential Pulmonary Arterial Hypertension Treatment

According to a story from globenewswire.com, the biopharmaceutical company Liquidia Technologies, Inc. just announced that the company’s New Drug Application (NDA) has been officially accepted by the US Food and Drug Administration (FDA) for review. This NDA is for the company’s experimental product candidate LIQ861, which is being developed as a treatment for pulmonary arterial hypertension (PAH), a rare lung disease.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplant. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.

About LIQ861

LIQ861 is a special powdered formulation of a drug called treprostinil, which was first approved as a treatment for this disease in 2002. It was developed using a innovative, proprietary technology from Liquidia called PRINT. PRINT is a platform for particle engineering. It allows for the production of very precisely engineered particulate drugs, which has the potential to improve the efficacy and safety of a wide variety of therapies. This powder is administered using a specially designed inhaler. The ultimate goal of this new formulation is to improve deep lung delivery of treprostinil, thereby increasing its effectiveness.

The FDA is aiming for a decision to be made on LIQ861 by November 24th, 2020. This experimental drug has the potential to give pulmonary arterial hypertension patients access to a more effective treatment for their disease.


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