FDA approves AbbVie/Biogen’s monthly MS jab, but with safety warnings

Biogen HQ

Biogen ($BIIB) and partner AbbVie ($ABBV) have won approval from the FDA for their new multiple sclerosis drug that can be used at home and only requires one injection a month--but the drug comes with a serious boxed warning.

The U.S. regulator announced late on Friday that it has allowed the two companies’ Zinbryta (daclizumab) to be used in patients with relapsing forms of multiple sclerosis (MS).

Zinbryta is a long-acting injection that is self-administered by the patient monthly--and may prove more appealing to patients as other, older treatments typically require more injections by a healthcare professional.

But there is some bad news, as it can only be used further down the pathway in patients who have had an inadequate response to two or more MS drugs.

This is because, the FDA says, Zinbryta has serious safety risks--including liver injury and immune conditions.

As a result of the risks, Zinbryta has had a boxed warning slapped on its label, and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy--something that will likely dampen sales as patients will need to have more frequent blood tests, also counteracting its inject-at-home appeal.

There are also a number of newer oral meds for MS, including Novartis’ ($NVS) Gilenya as well as Biogen’s own Tecfidera and its every-two-weeks MS treatment in Plegridy. Given its boxed warning and saturated market, peak annuals for the drug are currently at just $500 million, while some others have enjoyed sales peaking at $3 billion to $4 billion.

Geoffrey Porges, an analyst at Leerink Research, reiterates in a note to clients that the drug will see “modest” revenue given its boxed warning, limited efficacy compared to other MS treatments, and late arrival to an already large and well catered market.

Porges said: “We forecast modest uptake for Zinbryta, translating into $20 million in revenue in 2016 growing to $573 million in worldwide sales in 2020. Our forecast of Zinbryta’s 2020 revenue represents 6% of Biogen’s MS franchise and 4% of Biogen’s total revenue.”

"MS patients are in need of therapeutic choices to help manage their disease and Zinbryta is an important new option for patients," said Michael Severino, executive vice president of research and development and chief scientific officer, AbbVie, in a company release. "AbbVie is committed to making a remarkable impact on the lives of patients, including in MS where there are particular unmet needs."

The drug was passed on a number of trials, including a recent Phase III study which saw patients on Zinbryta having fewer clinical relapses than patients taking Biogen’s big-selling MS drug Avonex, with another trial also showing it reduced relapses better than placebo. In one trial, however, Zinbryta failed to significantly improve three-month disease progression.

The CHMP also recommended the drug be approved in Europe last month.

The drug is thought to work differently from other disease-modifying therapies by binding to CD25, a subunit of the interleukin-2 receptor found on activated lymphocytes, cells believed to underlie the biology of MS.

Roche ($RHHBY) and the small French biotech MedDay are working on late-stage tests (with Roche granted a Breakthrough Therapy Designation from the FDA this year) for their new MS drugs--although these are focused on progressive forms of MS, rather than relapsing, as both hope to carve out a new market in a subpopulation of the disease.

Roche’s drug has been seen by some analysts, including Tim Anderson, as being worth $7 billion at its peak.

- here’s the FDA’s release
- read AbbVie's release

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