Rx Product News: May 2022

BI 1015550

Manufactured by Boehringer Ingelheim

The FDA has granted breakthrough designation therapy status to an investigational treatment for individuals with idiopathic pulmonary fibrosis. BI 1015550, an oral phosphodiesterase 4B inhibitor, potentially could treat idiopathic pulmonary fibrosis and inflammation associated with progressive fibrosing interstitial lung disease. The treatment is being evaluated as both a monotherapy and a combination therapy with background antifibrotic therapies. The designation is based on a phase 2 double-blind, placebo-controlled, randomized trial (NCT04419506). The primary end point was the change from baseline in forced vital capacity over a 12-week treatment period.

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boehringer-ingelheim.com

Empagliflozin (Jardiance)

Manufactured by Boehringer Ingelheim

The FDA has approved Boehringer Ingelheim’s empagliflozin (Jardiance) as a treatment for lowering the risk of cardiovascular death and hospitalization for heart failure in adults. This makes empagliflozin the first approved therapy to demonstrate statistically significant risk reduction in cardiovascular death and hospitalization for heart failure regardless of ejection fraction. Adverse events in clinical studies with empagliflozin for individuals with heart failure were consistent with those for individuals with diabetes, the drug’s original target patients. The most common adverse events were urinary tract infections and fungal infections.

Mitapivat (Pyrukynd)

Manufactured by Agios Pharmaceuticals

The FDA has approved mitapivat (Pyrukynd; Agios Pharmaceuticals) for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency, which is a lifelong and rare hemolytic anemia. The FDA approval was based on results from the ACTIVATE (NCT03548220) and ACTIVATE-T (NCT03559699) studies, which included 2 groups of individuals: patients with pyruvate kinase deficiency who were not regularly transfused and those who were. Both studies met their primary end points. The most common adverse effects were arthralgia, back pain, and increased urate. Additionally, adverse effects included decreased estradiol and estrone for men.

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agios.com

PF-06928316 (RSVpreF)

Manufactured by Pfizer

The FDA has granted breakthrough therapy designation to PF-06928316 (RSVpreF; Pfizer), a respiratory syncytial virus (RSV) vaccine candidate, for the prevention of RSV-associated lower respiratory tract illness in infants from birth to 6 months by active immunization of pregnant individuals. The decision was based on the results of a phase 2b proof-of-concept study (NCT04032093) that assessed the immunogenicity and safety of the vaccine in healthy pregnant women and their infants. The pregnant women, aged 18 to 49 years, were vaccinated between 28 and 36 weeks of gestation. The vaccination uses a crystal structure of a key form of viral fusion protein that RSV uses to attack human cells.

FOR MORE INFORMATION:

pfizer.com