EU committee recommends combo tablet Yuvanci be approved for PAH
Opinion follows US approval of same PAH treatment of macitentan, tadalafil
A committee of the European Medicines Agency (EMA) has recommended that Yuvanci, a tablet containing macitentan and tadalafil, be approved for pulmonary arterial hypertension (PAH).
The positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) specifically recommends Yuvanci be approved for PAH in individuals with functional class 2 or 3, which includes patients who are mostly symptom-free at rest but experience notable symptoms when active, and who are already taking macitentan and tadalafil as separate tablets.
The CHMP’s recommendation comes a few months after the combination tablet was approved in the U.S., where it’s sold under the name Opsynvi. The CHMP’s opinion will now be reviewed by the European Commission, which has final say over medication approvals in the European Union. The commission isn’t obligated to follow the CHMP’s recommendations, but it almost always does.
“Today’s positive opinion represents a significant step forward and underlines our commitment to providing solutions for patients in the PAH community,” James F. List, MD, PhD, global therapeutic area head of cardiopulmonary at Johnson & Johnson Innovative Medicine, the company developing Yuvanci, said in a press release.
Macitentan, tadalafil approved individually for PAH
Macitentan and tadalafil are already approved individually for PAH, a disease marked by high pressure in the vessels that carry blood through the lungs. Macitentan is sold by Janssen as Opsumit, while tadalafil is marketed under the name Adcirca by United Therapeutics in the U.S. and by Eli Lilly in Europe. The two drugs work through different biochemical mechanisms, but both of them act to relax blood vessels, allowing them to widen and thereby reducing pressure in the vessels.
The two medicines are often prescribed in combination, which is recommended as the initial treatment for people with PAH, said Tamara Werner-Kiechle, MD, therapeutic area lead of neuroscience and cardiopulmonary for Johnson & Johnson Innovative Medicine’s Europe, Middle East and Africa division. Having both therapies available in a single pill “could represent an important new option for adults living with PAH who face complex treatment regimens,” Werner-Kiechle said.
The CHMP’s positive opinion for Yuvanci is based on data from a clinical trial called A DUE (NCT03904693), which also served as the basis for approval of Opsynvi in the U.S. The trial compared the combination pill against macitentan or tadalafil alone in 187 people with functional class 2 or 3 PAH. Results showed the combination led to better improvements in blood flow and heart health than either medicine alone.
Common side effects of the combo therapy seen in the A DUE trial included anemia (lack of healthy red blood cells or of hemoglobin to carry oxygen to the body’s tissues), swelling, and headache. Serious safety issues reported included anemia, swelling, low blood pressure, influenza, and intermenstrual bleeding (bleeding between periods).
“We continue our commitment to transform PAH into a manageable condition and we look forward to working with health authorities to bring our single tablet combination therapy to adult patients in need across the region as soon as possible,” List said.
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