Die US-amerikanische FDA genehmigt die Therapie von Merck für seltene Lungenerkrankungen

> The therapy, branded Winrevair, is approved for treating pulmonary arterial hypertension (PAH), which affects about 40,000 people in the United States.

> “We look forward to making a significant difference for these patients that are left with a disease where the five year mortality is 43%,” Jannie Oosthuizen, president of Merck’s U.S. Human Health business, told Reuters.

> Winrevair will carry a list price of $14,000 per vial, Oosthuizen said. According to data from the company’s trial, most patients will use a single vial every three weeks, which would translate to $238,000 per year.

…

> Winrevair, chemically known as sotatercept, becomes the first treatment to secure FDA approval from its class of drugs, which target a type of protein called activin that lead to higher levels of a follicle-stimulating hormone associated with the disease.

> PAH is caused by a constriction of arteries in the lungs, leading to high blood pressure and symptoms such as shortness of breath, chest pain and dizziness.

> The hypertension also makes the heart work harder to pump blood, eventually causing heart failure.

https://en.wikipedia.org/wiki/Pulmonary_hypertension

> As of 2022 there was no cure for pulmonary hypertension…

> The frequency of occurrence is estimated at 1,000 new cases per year in the United States. Females are more often affected than males. Onset is typically between 20 and 60 years of age. Pulmonary hypertension was identified by Ernst von Romberg in 1891.