FDA approves Opsumit for pulmonary arterial hypertension
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.
The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.
The FDA said the drug would carry a boxed warning, the highest warning possible, alerting patients and healthcare providers that Opsumit should not be used in pregnant women because it can harm a developing fetus. Women can only receive the drug through a risk evaluation and mitigation strategy program.
FDA approves new injector pen for Merck KGaA fertility drug
DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.
The drug maker — the U.S. subsidiary of Germany’s Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.
"With a complete portfolio of gonadotropins, Merck Serono is continuously innovating to improve its administration devices in order to meet the needs of patients and healthcare professionals," Merck Serono global head of research and development Annalisa Jenkins said. "We have a strong legacy in fertility, and the approval of the Gonal-F RFF Redi-ject in the [United States] further demonstrates our commitment to building our leadership position in this important therapeutic area as we look to the future."
Merck Serono, itself part of Merck KGaA, was originally the parent company of Merck & Co., but the two were split during World War I as part of a broader seizure of German assets in the United States.
FDA approves UCB’s Cimzia for ankylosing spondylitis
ATLANTA — The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.
The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.
"[Ankylosing spondylitis] is a lifelong disease that can cause pain and stiffness and, at times, can be very debilitating for people living with it," UCB EVP and chief medical officer Irish Loew-Friedrich said. "Cimzia provides an important new treatment option for people living with active AS an for rheumatologists."