The expanded indication of Selarsdi for the treatment of diseases such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease is expected to support the official launch early next year.
Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.
Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.