Johnson & Johnson’s Tracleer® (Bosentan Dispersible Tablets) Approved in China for Pediatric Pulmonary Arterial Hypertension

September 12, 2019/BioValleyBIOON/--Actelion, a Johnson & Johnson Janssen Pharmaceuticals company, recently announced that bosentan dispersible tablets (brand name: Tracleer®, generic name: bosentan) (strength: 32 mg) have been approved in China.Approved by the National Medical Products Administration (NMPA) for the treatment of pediatric pulmonary arterial hypertension (PAH), bosentan dispersible tablets (Tracleer®) have thus become the first medication approved in China for pediatric patients with PAH.

Pulmonary arterial hypertension is a chronic, life-threatening disease characterized by a significant increase in pulmonary artery pressure, which subsequently leads to right heart failure and severe reduction in exercise tolerance; in severe cases, it can result in patient death. Actelion is making every effort to accelerate the introduction of this treatment regimen to serve patients in China as soon as possible.Chinese patients.

It is worth noting that in late May this year, the Center for Drug Evaluation of the National Medical Products Administration released the "List of Urgently Needed Overseas New Drugs for Clinical Use (Second Batch)," which includes Tracleer (Opsynvi®), it is listed as clinically urgent due to being a medication for rare diseases and available in pediatric dosage forms. See link for details:CDE - Notice on the Release of the Second Batch of List of Overseas New Drugs in Urgent Clinical Need.

Tracleer is an orally active endothelin receptor antagonist (ERA) that was launched in 2001. It was the first approved medication for the treatment of pulmonary arterial hypertension (PAH) and has since been approved in numerous countries worldwide. In the United States, Tracleer 32 mg dispersible tablets were approved in September 2017.FDAApprovalThe drug is formulated as a scored tablet that can be dispersed in a teaspoon of water for oral administration. The low-dose strength and scored design of this new tablet enable physicians to adjust the prescribed dose according to the body weight of pediatric patients with pulmonary arterial hypertension (PAH).

Tracleer is an oral ERA that works by blocking the effects of excess endothelin produced in the patient's body. Endothelin is a naturally occurring chemical substance in the human body involved in blood flow. However, patients with PAH have higher levels of endothelin than normal individuals.. Studies have found that excessive endothelin leads to vasoconstriction, making it more difficult for blood to flow through the constricted vessels, which in turn affects the normal functioning of the heart.

Actelion, headquartered in Allschwil, Canton of Basel-Stadt, Switzerland, joined Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, after being acquired by Johnson & Johnson for $30 billion in cash in June 2017. Actelion is a market leader in the field of pulmonary arterial hypertension (PAH), with itsActelion’s portfolio of pulmonary arterial hypertension (PAH) treatments covers the full spectrum of the disease, from WHO Functional Class II to IV, including oral, inhaled, and intravenous formulations. Over the past two decades, Actelion’s products have significantly helped a broad population of PAH patients improve their prognosis and quality of life. YangJohnson & Johnson has now designated pulmonary arterial hypertension as a key therapeutic area to consolidate and expand Actelion’s leading position in this field. (Bioon.com)

Original Source: Janssen Pharmaceuticals