Actelion announces U.S. commercial availability of OPSUMIT (macitentan)

Date: Nov-06-2013Actelion (SIX: ATLN) has announced the commercial availability of OPSUMIT® (macitentan) 10mg, an oral, dual endothelin receptor antagonist (ERA) approved for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression. PAH is a chronic, life-threatening disorder that can severely compromise the function of the lungs and heart. The U.S. Food and Drug Administration (FDA) approved OPSUMIT on October 18, 2013.

OPSUMIT® is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

"OPSUMIT is a clinically proven treatment option that is the first drug to demonstrate, in a randomized, controlled study, delay in disease progression for PAH over the long term. I am very pleased to be able to offer my patients suffering from this debilitating disease a new treatment option," said Richard Channick, MD, director, Pulmonary Hypertension and Thromboendarterectomy Program, Massachusetts General Hospital, Boston.*

"The availability of OPSUMIT in the U.S. marks a significant milestone for physicians and patients. They now have a treatment option available that is shown to improve both short-term physical functioning and long-term PAH outcomes," said Bill Fairey, president of Actelion Pharmaceuticals U.S. "Actelion is committed to bringing this important treatment to patients suffering from PAH and has therefore established a patient support program to provide access to OPSUMIT."

"All of us at the Pulmonary Hypertension Association are excited when new treatments become available. We know that not all treatments work for all patients and having new options - whether used alone or in combination with other therapies - means that physicians have more opportunities for helping their patients," said Rino Aldrighetti, president and CEO of the Pulmonary Hypertension Association.

The efficacy of OPSUMIT was established in the SERAPHIN study, a long-term study of 742 PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of two years. OPSUMIT is the only oral PAH treatment that has proven efficacy on long-term PAH outcomes and hospitalizations. [1]

Opsumit® carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit REMS Program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counseled regarding the need for contraception.

The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with Opsumit® were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

Physicians are advised to measure hemoglobin and liver enzymes prior to initiation of Opsumit® and repeat during treatment as clinically indicated.

OPSUMIT is available in 10 mg tablets for once-daily oral administration. Full prescribing information can be found on the product website at www.Opsumit.com

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.