2023-04-28 05:57:43 ET
- A committee of the European Medicines Agency (EMA) recommended the expanded approval of Bayer ( OTCPK:BAYRY ) ( OTCPK:BAYZF ) pulmonary arterial hypertension (PAH) drug Adempas for use in children.
- Pulmonary hypertension is a type of high blood pressure which affects the arteries in the lungs and the right side of the heart. In PAH the blood vessels in the lungs are narrowed, blocked or destroyed which slows down blood flow in the lungs and blood pressure in the lung arteries rises.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) backed the use of Adempas (riociguat) to treat PAH in pediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) 2 to 3 in combination with endothelin receptor antagonists.
- Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated to treat adults with PAH, the CHMP noted.
- The European Commission (EC) will now make a final call on the change to the marketing authorization of the drug.
For further details see:
Bayer's Adempas for high blood pressure in lungs gets EMA nod for use in children