Tuesday, January 03, 2017

The issue of two competing drugs for a single condition, with one offered at a significantly cheaper price

Of the "drug patent" matter discussed in medcitynews, the recent flurry of excitement in the MS community over the drug Ocrelizumab brings up another issue [that of two competing drugs for a single condition, with one offered at a significantly cheaper price. ]

As background to Ocrelizumab, see the post in managedcare magazine Finally, Attention Switches To Progressive Multiple Sclerosis including

Ocrelizumab is novel and achieved its breakthrough designation because it selectively binds to and depletes CD20-positive B cells.


By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream, explains Dhib-Jalbut.

See also WebMD

Drug Shows 'Breakthrough' Promise for Advanced MS

Specialist hopes ocrelizumab will be available by spring

, including

Ocrelizumab, under the brand name Ocrevus, is awaiting approval by the U.S. Food and Drug Administration. The FDA had been set to approve the drug this month, but recently extended its review into March.



New drug gives hope for those with progressive multiple sclerosis , including

Neurologist Dr. Fred Lublin of Mount Sinai Hospital in New York City worked on the trial.

“It’s a very big deal. You have to start with success and this is the start. And so this is for us the start of treating progressive MS, the treating progressive MS era,” he said.

**As to "newness" and novelty, the clinical trial results are encouraging. But the basic idea is not so new. From an IPBiz post Northwestern/UChicago work on multiple sclerosis [MS]

Rituximab targets CD20 expressed on pre-B and mature B cells, depleting these cells in the circulation and CNS [Naismith et al. 2010]. Although MS was traditionally considered a T-cell mediated disease, accumulating evidence suggests that B cells play a role. As addon therapy, rituximab decreased the number of Gd-enhancing lesions in a phase II trial of patients with an inadequate response to standard injectable DMTs [Naismith et al. 2010]. In study patients with primary progressive MS, rituximab slowed increases in T2 hyperintense lesion volume but did not prolong time to confirmed disease progression compared with placebo [Hawker et al. 2009]; however, a subgroup analysis found that disease progression was slowed in patients younger than 51 years of age with ⩾1 Gd-enhancing lesion [Hawker et al. 2009].

and note also

Ocrelizumab and rituximab for multiple sclerosis


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