FDA Approves Generic Bosentan Tablets in US for PAH Treatment

Alice Melão, MSc avatar

by Alice Melão, MSc |

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A new generic version of Actelion’s Tracleer (bosentan) developed by Teva Pharmaceutical was approved by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH).

The decision was supported by evidence that the generic bosentan has similar biochemical properties to its reference-approved therapy, so it holds therapeutically equivalent activity to Tracleer.

Teva’s bosentan tablets will be available in most U.S. pharmacies in two doses — 62.5 mg and 125 mg — for the treatment of PAH.

Because of the high risk of liver damage and serious birth defects previously reported for Tracleer, the new bosentan tablets will be available only through a restricted distribution program required by the FDA, called the Bosentan REMS Program.

“The launch of bosentan tablets in the U.S. is an important addition to Teva’s generics portfolio,” Brendan O’Grady, executive vice president, head of North America commercial at Teva, said in a press release. “We are proud to offer another generic treatment option to patients living with this chronic condition.”

Join the PH forums: an online community especially for patients with pulmonary hypertension.

Bosentan is an endothelin receptor antagonist that works by reducing the amount of endothelin in the blood. Endothelin causes blood vessels in the lungs to narrow, increasing blood pressure in the pulmonary arteries.

Similar to its reference therapy, generic bosentan tablets are indicated for the treatment of patients 12 or older in the WHO group 1 category. The therapy aims to improve patients’ capacity to exercise and to slow the progression of the disease.

Clinical data have demonstrated that bosentan can improve patient scores in a test that measures how far a person can walk over six minutes, reduce mean pulmonary arterial pressure, and increase cardiac index, which measures the amount of blood the heart pumps in one minute.

Bosentan can also reduce vascular resistance in the lungs (which improves blood flow), and limit patients’ clinical and functional worsening.

A recent study has also suggested that bosentan, as marketed under the brand name Tracleer, can be more cost-effective for the treatment of PAH than epoprostenol medications or palliative care.

The most common adverse reactions associated with bosentan are respiratory tract infection, anemia, headache, edema (abnormal accumulation of fluid), chest pain, flushing, hypotension, sinusitis, joint pain, and palpitations.

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