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J&J's Tuberculosis Drug Gets FDA Nod for Adolescent Patients

Zacks Equity Research

Johnson & Johnson JNJ announced that the FDA has granted accelerated approval to its antimycobacterial tablets, Sirturo (bedaquiline) as a combination therapy to treat adolescents with pulmonary multidrug-resistant tuberculosis (MDR-TB).

Sirturo is already marketed in combination with a background regimen for treating MDR-TB in adults. Continued approval for the adolescent indication will be based on verification of data from confirmatory studies. A similar application is also under review in the EU.

The approval for Sirturo in adolescents patient group (12 to less than 18 years of age and weighing at least 30 kg) was based on a cohort of a J&J phase II pediatric pharmacokinetic and safety study, C211. The other cohorts of the study are evaluating Sirturo in pediatric patients in different age groups. For the adolescent patient group, the formulation (100 mg tablet) and the dosing recommendation are the same as those approved for adults. 

Tuberculosis is a deadly infectious disease, which claimed the lives of 230,000 children in 2017. Though it is more common in adult patients, all age groups are at risk.

J&J’s stock has risen 2.3% this year so far against a decrease of 1.3% recorded by the industry.



J&J currently has a Zacks Rank #3 (Hold). Some better-ranked large-cap pharma stocks are Roche Holding AG RHHBY, Sanofi SNY and Merck MRK. While Roche sports a Zacks Rank #1 (Strong Buy), Sanofi and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Roche have gained 12.3% this year so far. Earnings estimates for 2019 have risen 0.8% while that for 2020 have increased 2% over the past 30 days.

Sanofi’s earnings estimates have increased 0.3% and 0.9%, respectively, for 2019 and 2020 over the past 30 days.

Merck’s stock is up 11.9% this year so far. Its earnings estimates have risen almost 3% for 2019 and 1.7% for 2020 over the past 30 days.

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