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Two Big FDA Approvals Expected Next Week

Ocrevus and Dupixent set to make a splash

Given earlier impressive clinical trial results, investors expect the FDA to clear both Roche’s multiple sclerosis (MS) treatment ocrelizumab (Ocrevus) and Sanofi’s new eczema drug dupilumab (Dupixent), according to a Reuters report. The two FDA decisions, due by March 28 and 29, respectively, mark important landmarks for both firms, since ocrelizumab and dupilumab are expected to be the biggest new drug launches from the global pharmaceuticals industry in 2017.

The success of ocrelizumab against two types of MS in clinical studies will help Roche diversify beyond cancer, Reuters says. The drug has beaten rivals in fighting relapsing-remitting MS and could become the only FDA-approved drug for patients with primary progressive MS (PPMS).

Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal damage. This nerve-cell damage can lead to disability in people with MS. Ocrelizumab binds to CD20 cell-surface proteins expressed on certain B cells, but not on stem cells or plasma cells, thereby preserving important functions of the immune system.

The ORATORIO trial was a global, phase 3, randomized, double-blind study of ocrelizumab (600 mg administered by intravenous infusion every six months, given as two 300-mg infusions two weeks apart) compared with placebo in 732 patients with PPMS. The blinded treatment period continued beyond two years until all of the patients had received at least 120 weeks of treatment with ocrelizumab or placebo and a predefined number of confirmed disability progression (CDP) events was reached in the study.

Key study findings included:

  • A 24% relative risk reduction in CDP sustained for at least 12 weeks compared with placebo (P = 0.03)
  • A 25% relative risk reduction in CDP sustained for at least 24 weeks compared with placebo (P = 0.04)
  • A 29% relative reduction in the time required to walk 25 feet compared with placebo during 120 weeks of treatment (P = 0.04).
  • A 3.4% reduction in the total volume of brain hyperintense T2 lesions compared with a 7.4% increase in the placebo group during 120 weeks of treatment (P < 0.001).
  • A 17.5% relative reduction in the rate of whole-brain volume loss compared with placebo from week 24 to week 120 (P = 0.02).

As for dupilumab, Sanofi’s research head told Reuters that the product marks a new era of successful innovation for the company, although Sanofi is in a patent dispute with Amgen.

Dupilumab inhibits signaling of interleukin (IL)-4 and IL-13, two cytokines required for the type-2 (including Th2) immune response, which is believed to be a major driver in atopic dermatitis (AD) and in certain atopic or allergic diseases, including asthma and nasal polyposis.

Two phase 3, placebo-controlled studies––SOLO 1 and SOLO 2––evaluated dupilumab in adults with inadequately controlled moderate-to-severe AD. At 16 weeks in the two trials, respectively, 37% and 36% of the subjects who received dupilumab 300 mg weekly, and 38% and 36% of the subjects who received dupilumab 300 mg every two weeks, achieved clearing or near-clearing of skin lesions, as measured by the five-point Investigator’s Global Assessment (IGA) scale, compared with 10% and 8% of the subjects given placebo (P < 0.0001). This was the primary endpoint in the U.S. and one of the primary endpoints in the European Union.

Dupilumab, developed with Regeneron Pharmaceuticals, is forecast to sell $4.2 billion annually by 2022, with ocrelizumab reaching $4.0 billion by that date, according to a consensus of analysts’ estimates compiled by Thomson Reuters.

Sources: Reuters; March 23, 2017; Roche; December 21, 2016; and Sanofi; October 1, 2016.

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