Sanofi and Regeneron's Dupixent gets more positive feedback from U.S.FDA
PARIS: The U.S. Food & Drug Administration (FDA) regulator has given more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron, the companies said.
Dupixent was launched in the United States in April 2017 for the treatment of moderate-to-severe eczema in adults, and the product is seen as a key sales driver for both companies.
They said the FDA had accepted for a priority, or expedited, review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis, where the disease was inadequately controlled with topical therapies, or when such treatment was medically inadvisable.
Last month, Dupixent also received approval from the FDA as an additional maintenance therapy in patients with two types of asthma.
Read Also: Sanofi drug Dupixent wins USFDA approval to treat asthma
Sanofi and Regeneron are developing Dupixent to treat conditions including paediatric asthma, chronic sinus infection with nasal polyps, and adolescent eczema.
Dupixent was launched in the United States in April 2017 for the treatment of moderate-to-severe eczema in adults, and the product is seen as a key sales driver for both companies.
They said the FDA had accepted for a priority, or expedited, review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis, where the disease was inadequately controlled with topical therapies, or when such treatment was medically inadvisable.
Last month, Dupixent also received approval from the FDA as an additional maintenance therapy in patients with two types of asthma.
Read Also: Sanofi drug Dupixent wins USFDA approval to treat asthma
Dupixent had revenues of 225 million euros ($256.8 million) in the third quarter, Sanofi reported in October, as the company also lifted its overall 2018 profit target.
Sanofi and Regeneron are developing Dupixent to treat conditions including paediatric asthma, chronic sinus infection with nasal polyps, and adolescent eczema.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd