FDA: First Treatment Option for Pediatric PAH

The US Food and Drug Administration has approved Tracleer^® (bosentan) for patients age 3 years or older who have idiopathic or congenital pulmonary arterial hypertension (PAH). This is the first FDA-approved drug for pediatric patients with PAH in the United states.

Tracleer is administered orally and is used to improve pulmonary vascular resistance, which is expected to improve exercise ability in patients.

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The drug is approved in new 32 mg dose tablets, which have score lines on them to allow physicians to prescribe doses based on the patient’s weight.

Due to the risks of hepatotoxicity and birth defects, Tracleer includes a boxed warning and is only available through the restricted Tracleer REMS Program. Patients, prescribers, and pharmacies must enroll in the program to receive and administer Tracleer.

In addition, the most common adverse events associated with Tracleer in clinical trials include respiratory tract infections, headache, edema, chest pain, syncope, flushing, hypotension, sinusitis, arthralgia, abnormal serum aminotransferases, palpitations, and anemia.

—Melissa Weiss

Reference:

Actelion receives FDA approval of Tracleer (bosentan) for use in pediatric patients with pulmonary arterial hypertension [press release]. South San Francisco, CA: Johnson & Johnson, September 6, 2017. https://www.jnj.com/media-center/press-releases/actelion-receives-fda-approval-of-tracleer-bosentan-for-use-in-pediatric-patients-with-pulmonary-arterial-hypertension. Accessed September 7, 2017.