J&J (JNJ) PAH Drug's U.S. Label Expanded For Pediatric Use

Johnson &Johnson (NYSE:JNJ) , a healthcare bellwether, announced that the FDA has approved a label expansion for its oral pulmonary arterial hypertension (PAH) medicine, Tracleer.

Consequently, a 32 mg tablet of Tracleer is now approved for use in pediatric patients aged three years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. With the approval, Tracleer has become the first medicine in the U.S. to be approved for use in pediatric patients. The 32 mg oral suspension formulation for pediatric use is expected to be available in the fourth quarter of this year. Presently, Tracleer is marketed in 62.5 and 125 mg dosages for adult patients. These will still be available.

We remind investors that Tracleer and other PAH drugs including Opsumit, Ventavis, Veletri and Uptravi were added to J&J’s portfolio with the acquisition of Swiss biotech, Actelion. J&J acquired Actelion in June this year for $30 billion, which diversified the former’s revenues in the PAH category.

Actelion’s newer drugs – Opsumit and Uptravi – have been well received and are poised to become blockbuster drugs. However, Tracleer, an older medicine is facing competitive pressure. We believe the label expansion for pediatric use should improve sales of Tracleer, going forward.

PAH is a chronic life-threatening disease characterized by increased blood pressure in the pulmonary arteries. The PAH market is highly attractive given the low diagnosis rate, low penetration of existing therapies and significant unmet medical need.

Other than Actelion, United Therapeutics Corporation (NASDAQ:UTHR) holds a strong position in the PAH market with as many as four approved products - Remodulin, Adcirca, Tyvaso and Orenitram. Pfizer’s (NYSE:PFE) Revatio is used for the same indication as well. Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) has ralinepag in its pipeline, which is also being developed for PAH.

So far this year, J&J’s share price has increased 13.4%, comparing favorably with a gain of 11.8% recorded by the industry it belongs to.

J&J carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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