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Tech & Science Novartis launches review into safety of eye drug Beovu

12:45  25 february  2020
12:45  25 february  2020 Source:   reuters.com

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Beovu exhibited an overall safety profile comparable to aflibercept. Beovu is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or with known hypersensitivity to brolucizumab or any of the excipients in Beovu [1]

All wet AMD drugs require injections into the eye , however Novartis said that Beovu 's less-frequent dosing presented a differentiating factor to rivals. "From a retina specialist perspective, the feedback has been really positive," Mr. Spittle said. "We believe we can quickly take market share," he added.

a sign on the side of a building: FILE PHOTO: Logo is seen at new factory of Novartis in Stein © Reuters/Arnd Wiegmann FILE PHOTO: Logo is seen at new factory of Novartis in Stein

ZURICH (Reuters) - Novartis has launched an external review into the safety of its blindness medicine Beovu after the American Society of Retinal Specialists (ASRS) raised concerns.

The Swiss drugmaker's shares fell nearly 3% in early trading after the ASRS communicated to its members about the drug, a replacement for Novartis' blockbuster Lucentis.

Since Beovu's approval last October, ASRS has received reports of 14 cases of vasculitis, an inflammation of the blood vessels, of which 11 were designated occlusive retinal vasculitis - a sight-threatening inflammatory eye condition.

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The Swiss drug maker reported million in Beovu sales for the fourth quarter. Novartis is targeting blockbuster status for the drug , which means eventually reaching over billion in annual revenue. All wet AMD drugs require injections into the eye , however Novartis said that Beovu 's less-frequent

Beovu is a key drug for Novartis in its eye care franchise as the Lucentis product the company sells in Europe nears the end of its patent life. In a highly competitive market Beovu will compete with Lucentis, Bayer's BAYGn.DE Eylea and a new product that Novartis rival Roche ROG.S has under development.

Novartis said it was aware of recently reported adverse effects of the drug, adding it "stands behind the safety and efficacy of Beovu."

"In addition to our own internal assessment, we have engaged an external safety review committee (SRC) to further evaluate these post-marketing cases. We will continue to share details as they become available," the company said.

Around 46,000 injections of Beovu have so far been administered, Novartis said. The U.S. Food and Drug Administration was aware of the review, while the company is now informing other health authorities.

"Our clinical development and pharmacovigilance teams are working with healthcare professionals to quickly obtain and evaluate all available information in order to classify these events and identify potential risk factors," Novartis said.

The company received approval from the FDA for Beovu in October and the go-ahead in Europe earlier this month.

Beovu injections are used to treat wet age-related macular degeneration, a condition which can eventually lead to blindness and affects around 20 million people worldwide.

(Reporting by John Revill; editing by Jason Neely, Kirsten Donovan)

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