The European Committee for Medicinal Products for human use has approved AbbVie Inc. (NYSE:ABBV) Humira for the treatment of chronic non-infectious anterior uveitis in pediatric patients. The approval provides a new treatment option for children with the serious and potentially blinding condition.
CHMP Humira Opinion
Uveitis is a medical condition characterized by inflammation of the Iris choroid and the ciliary body of the eye. If untreated the condition can lead to vision loss causing glaucoma and cystoid macular edema, The positive CHMP opinion is based on positive results from the SYCAMORE clinical trial.
The study analyzed the clinical effectiveness and safety of Humira when combined with methotrexate. Clinical trial results indicate that Humira in combination with methotrexate controlled ocular inflation better, with a significantly lower rate of treatment failure.
“Today’s positive CHMP opinion marks a significant milestone for pediatric uveitis patients and their caregivers […] it is also a reflection of Abbvie’s commitment to providing therapies for both adult and pediatric patients living with immune-mediated diseases,” said AbbVie vice president of immunology development
AbbVie awaits a review of a market authorization application whose decision will be made public in September. Approval would mark yet another milestone achievement in the company’s bid to strengthen sales in its immunology portfolio.
A marketing authorization will pave way for AbbVie to market Humira in the 28 member states as a novel treatment for chronic non-infectious anterior uveitis. The drug is currently approved in the region for the treatment of non-infectious posterior and pan uveitis in adults.
Q2 Earnings
Separately, AbbVie is to release its second quarter earnings on July 28, 2017. The outcome will have a huge impact on the stock’s direction of trade, given that it is already up by 10.2% for the quarter and 14.5% for the full year.
AbbVie management expects second quarter earnings to range $1.39 and $1.41 a share with revenues increasing by between 7% and 8%. However, the company also expects currency headwinds to hurt revenues by 1%. The company’s lead drug Humira should remain the key driver of revenues as well as earrings.
AbbVie stock was up by 0.84% in Friday’s trading session to end the week at $74.63 a share.
