FDA grants approval for Incyte's Opzelura cream in managing atopic dermatitis condition
The U.S. Food and Drug Administration (FDA) has broadened the approved use of Opzelura cream, a topical treatment for eczema, to include adolescents aged 12 and older.
Opzelura cream, with the active ingredient ruxolitinib and a strength of 1.5%, has been approved for the chronic treatment of mild to moderate eczema. The FDA's decision to approve Opzelura cream for adolescents marks an expansion of its previously approved uses, which were limited to children aged two and above.
Dr. Peter Lio, M.D., Clinical Assistant Professor of Dermatology & Pediatrics at Northwestern University Feinberg School of Medicine, was recommended by the FDA for the further development and expert comment on Opzelura Cream 1.5% for the chronic treatment of mild to moderate eczema in non-immunocompromised children aged two and over, and adolescents.
The FDA's approval of Opzelura cream for adolescents reinforces its focus on addressing the needs of patients with mild to moderate eczema. The approved condition for Opzelura cream remains mild to moderate eczema, and the treatment is not intended for acute or short-term use.
It is important to note that the FDA's approval of Opzelura cream for adolescents applies only to the U.S. market. The approved age range for Opzelura cream use includes adolescents, in addition to children aged two and above. The newly approved usage of Opzelura cream is for chronic treatment in adolescents, maintaining the focus on long-term management of eczema.
Incyte, the company behind Opzelura, trades on the NASDAQ under the symbol INCY. The FDA's approval of Opzelura cream for adolescents follows its initial approval for the treatment of eczema in children aged two and above.
As always, it is crucial for patients to consult with their healthcare providers before starting any new treatment. Opzelura cream, like any medication, may have potential side effects, and it is important to discuss these with a healthcare professional.
In summary, the FDA has approved Opzelura cream for the chronic treatment of mild to moderate eczema in non-immunocompromised adolescents aged 12 and above. This expansion of approved use reflects the FDA's commitment to addressing the needs of patients with eczema and improving the long-term management of this condition.
