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Roche wins FDA approval for 1st self-administered biologic for rare eye disease.

The Food and Drug Administration approved Roche's Enspryng, the first biological drug that patients can inject themselves to treat a rare autoimmune disorder affecting the optic nerve.

The announcement on Friday came two months after the agency gave its blessing to Viela Bio's Uplizna, pitting the small biotech against larger companies in Roche and Alexion Pharmaceuticals in neuromyelitis optica spectrum disorder (NMOSD), which affects about 10,000 people in the U.S.

Against the backdrop of tens of thousands of U.S. residents being diagnosed with coronavirus infections every day, Roche highlighted Enspryng's self-administration as one of the drug's key advantages. Uplizna and Alexion's Soliris require patients to receive intravenous infusions at healthcare facilities, heightening the risk of infection for patients on immunosuppressive treatments.

NMOSD results from an autoimmune reaction that causes inflammation in the optic nerve and spinal cord, causing loss of vision and mobility problems. It is often misdiagnosed as multiple sclerosis because the symptoms are similar, and one of the ways physicians can identify NMOSD patients is when brain scans don't reveal the lesions that are characteristic of MS.

To treat NMOSD, doctors use immunosuppressive therapies like azathioprine and steroids as first-line agents, and add biologics to help patients that continue to experience symptoms. Roche's Rituxan has been used off-label, but last year Alexion's Soliris won the first-ever formal FDA approval for the disease. 

That was followed in June by Uplizna. However, because that drug acts similarly to Rituxan by depleting a certain type of immune cell, Stifel analyst Derek Archila questioned in a June 18 note to clients how many physicians will prefer Uplizna over Rituxan. That is especially true since Rituxan biosimilars have entered the market, lowering the annual cost to around $33,000-$37,000 a year compared with the $262,000 annual cost of Uplizna when patients are on maintenance dosing.

Moreover, Archila wrote that if patients relapse on Rituxan, then physicians may be more likely to switch to a different type of drug like Soliris, in spite of its $700,000 price tag. The same may be true for Enspryng, he wrote, because it works by blocking a chemical that stimulates an immune-cell response, rather than depleting the immune cells themselves.

Payers may also favor Enspryng because it can be injected at home by patients or their caregivers, Archila wrote. Intravenous infusions carry with them additional costs because they have to be administered by specialists in healthcare facilities, something that could offer a "tailwind" to Enspryng, Archila wrote.

Author:Jonathan Gardner


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