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FDA greenlights Merck lung disease drug acquired in $11B deal

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FDA greenlights Merck lung disease drug

With clearance for pulmonary arterial hypertension, Merck anticipates that Winrevair will become a blockbuster drug. However, its potential might depend on the outcomes of a few ongoing experiments.

The FDA approved a new medication from Merck & Co. to treat pulmonary arterial hypertension. Winrevair is a medication that treats the main cause of a lung disease that can be fatal within ten years of being diagnosed.

The FDA approved Winrevair based on data from clinical trials that showed it improved quality of life and exercise duration while delaying the disease's progression or death.

The injection, scientifically referred to as sotatercept, inhibits proteins that thicken lung blood vessel walls, which raises blood pressure, strains the heart, and causes symptoms like exhaustion, shortness of breath, and chest pain. It is given out every three weeks.

Currently, a variety of medications, all of which are vasodilators that aid in dilating blood vessels, are used to treat PAH. Products prescribed for the problem include Tyvaso from United Therapeutics and Opsumit and Uptravi from Johnson & Johnson.

Medications only hide the symptoms of the illness and do not treat the root cause. For instance, they may improve one's ability to exercise, but they do not address the biological factors that contribute to the progression of PAH.

A study called Stellar, led by Merck and involving 323 stable PAH patients already on their medications, was crucial to the approval of Winrevair. Every three weeks, the participants were randomly assigned to either a placebo or Winrevair. The drug's effectiveness was evaluated using the six-minute walk test, a commonly used tool for assessing cardiovascular disease.

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