FDA Pipeline preview, September 2008

The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.

Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.

The recent study also found that Jardiance for patients with heart failure with preserved ejection fraction could be cost-effective if discounted by 29%.

Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.

Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.

Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.