Actelion Pharmaceuticals UK has launched Opsumit (macitentan), which is now available on prescription in England as a new treatment option for patients with pulmonary arterial hypertension (PAH).
PAH is a severe, life-threatening illness characterised by abnormally high blood pressure in the arteries between the heart and lungs. Despite advances in treatment, it remains a progressive disease with high death rates.
Opsumit is a new endothelin receptor antagonist (ERA) used as a monotherapy or in combination with other medicines for the long-term treatment of PAH in adults whose disease has reached a certain level of severity (WHO Functional Class [FC] II to III).
Following completion of the SERAPHIN study, Opsumit had secured EU marketing authorisation in December 2013.
Hammersmith Hospital consultant respiratory physician Luke Howard said PAH is a chronic condition, with significant impacts on patients’ quality of life, symptoms and survival.
“For many years, the PAH medical community and commissioners of specialised NHS services have been asking for a drug with a demonstrated benefit in reducing morbidity-mortality events, and for the first time, with macitentan (Opsumit), we have this, supported by data from SERAPHIN, the longest and largest clinical trial in PAH,” Howard added.
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By GlobalDataEfficacy of the drug has been demonstrated in a PAH population, including idiopathic and inherited PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
The company said that efficacy was also demonstrated in treatment naive patients and those already receiving PAH-specific background therapies, such as phosphodiesterase type 5 inhibitors (PDE 5i).
Actelion Pharmaceuticals UK general manager Robin Bhattacherjee said England is one of the first countries in Europe to make Opsumit available to prescribe.
“This milestone further demonstrates Actelion’s ongoing commitment to the discovery, development and commercialisation of innovative treatments, which offer real benefits for patients,” Bhattacherjee said.
Opsumit’s approval in Europe was based on data from the Phase III SERAPHIN trial showing that the drug resulted in a 45% relative risk reduction of the composite morbidity-mortality endpoint when compared with placebo, a treatment effect long sought after by healthcare professionals.
Macitentan 10mg also showed a reduction in the risk of PAH related death or hospitalisation for PAH up to end of treatment (EOT) by 50% RRR.
Most commonly reported adverse drug reactions with the drug are nasopharyngitis, headache and anaemia, while the majority of adverse reactions reported were mild to moderate in intensity.
Image: Micrograph showing a plexiform lesion of the lung, as seen in irreversible pulmonary hypertension. Photo: courtesy of Patho.