AbbVie's HUMIRA Gets EU Regulator's Positive Opinion To Treat Some Non-Infectious Uveities Types

AbbVie Inc. ABBV revealed Friday that the European Union regulator, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has granted a positive opinion for its HUMIRA. According to the company, this would help treat non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is inappropriate.

AbbVie said that HUMIRA could also drag corticosteroid use in corticosteroid-dependent patients. The drug maker added that Non-infectious uveitis is a group of diseases characterized by inflammation of the uvea, the middle layer of the eye. The company believes that it could lead to reduced vision or vision loss and is the third-leading cause of preventable blindness worldwide.

The company said that if the European Commission granted marketing authorization for HUMIRA, then it would become the first and only biologic treatment available for non-infectious intermediate, posterior and panuveitis.

AbbVie's EVP, R&D and Chief Scientific Officer, Michael Severino, reacted to say, "Today's CHMP opinion marks a key milestone towards HUMIRA becoming the first approved biologic medication for uveitis, an inflammatory condition of the eye that can impact vision. Current treatment options are limited and sometimes ineffective. Building on more than 18 years of clinical experience with HUMIRA across indications, we hope to make an impact on the lives of more patients with unmet needs."

Similarly, Ophthalmology Professor, Glen Jaffe, said that "With limited treatment options for non-infectious uveitis, this recommendation is a step toward progress for people living with a disease that has potentially profound effects on vision. The data from the VISUAL clinical trial program demonstrate the safety and efficacy profile of HUMIRA in patients living with particular forms of non-infectious uveitis."

The drug maker said that the review of the marketing authorization application (MAA) was being conducted under the centralized licensing procedure. Once approved, the authorization would become a valid one in all 28 member States of the European Union apart from Iceland, Liechtenstein and Norway.

AbbVie said that since first gaining marketing authorization 13 years ago, its HUMIRA has been approved in over 90 countries. Currently, it is being used to treat over 989,000 patients throughout the world across 13 globally approved indications.