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Bayer and Regeneron eye drug gains another indication

pharmafile | March 26, 2015 | News story | Sales and Marketing Bayer, Eylea, FDA, Japan, Lucentis, MRI, Regeneron, aflibercept 

Bayer and Regeneron’s Eylea has added to a growing list of indications with its new approval to treat a type of diabetic eye disease in the US.

The FDA nod expands the eye drug’s use to include diabetic retinopathy (DR) in patients with diabetic macular edema (DME). It gained breakthrough therapy and priority review designation for this condition in 2014.

Eylea (aflibercept) is not the first injectable FDA-approved drug for DR – that title went to Roche with its rival Lucentis (ranibizumab) in February. However, Regeneron notes that Eylea requires less regular dosing than Lucentis.

“Diabetes is a serious public health crisis, affecting more patients every year,” says Edward Cox, director of the office of antimicrobial products in the FDA’s center for drug evaluation and research. “Today’s approval gives patients with DR and DNE another therapy to treat this vision-impairing complication.”

DR causes abnormal new blood vessels to grow on the surface of the retina that can subsequently break and leak. Because of this it is a leading cause of blindness. In the US in 2008, 33% of adults with diabetes over 40 had some form of DR.

Eylea is also approved for wet age-related macular degeneration (wet AMD) and retinal vein occlusion (RVO), and in February it gained EU approval to expand this indication to include branch retinal vein occlusion (BRVO).

Regeneron has exclusive rights to the drug in the US while Bayer licensed the marketing rights for other regions, where the companies have equal share of any profits from its sales.

Eylea had sales of $2.8 billion in 2014, and was one of the five new products that the German firm cited for driving a year-on-year sales increase of 11.2% for its pharmaceutical business in its 2014 financial results.

New Japanese approval for Bayer

The company has also seen success in Japan this week, as its gadolinium-based MRI contrast agent Gadovist (gadobutrol) was approved in the country.

Contrast agents are used to enhance the visibility of certain parts of the body in MRI scans. Gadovist is formulated at the twice the concentration of other gadolinium-based contrast agents, and Bayer says that it also has a shorter relaxation time than other agents, which can improve signal intensity.

“The approval of Gadovist in Japan provides local radiologists with access to the first high concentration/high relaxivity gadolinium-based agent,” says Dr Christiane Pering, chief medical officer and head of innovation in Bayer HealthCare’s medical care division.

“It has demonstrated efficacy in providing the potential of high quality images of the central nervous system and whole body for patients, supporting effective diagnosis and disease management by their healthcare teams and ultimately enabling good patient care.”

George Underwood

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