July 17, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Mass.-based Biogen, Inc. reported yesterday that a second patient taking the company’s multiple sclerosis drug Tecfidera (dimethyl fumarate) has developed a non-fatal case of progress multifocal leukoencephalopathy (PML).
PML is a brain infection and may initially present as new or worsening weakness in the body. Also, PML may start with eye problems, strength or balance issues. Tecfidera has been shown to help MS patients reduce attacks or relapses. In clinical trials, about 4,000 patients took the drug and the company indicates that more than 100,000 patients have taken it since it was approved by the FDA in 2013.
On Nov. 25, 2014, the FDA announced that a patient receiving Tecfidera for MS died of PML. The woman had been taking the drug for four years. The FDA stated that, “Prior to developing PML, the patient had a very low number of lymphocytes, a type of white blood cell, in her blood. Reduced lymphocyte counts can weaken the immune system, which increases the risk for PML. It is unknown whether the low lymphocyte count contributed to the development of PML in the patient, or if low lymphocyte counts are a risk factor for PML development in Tecfidera-treated patients.”
In April 2015, Dutch physicians published a case study in The New England Journal of Medicine that described a patient who died from a reaction to dimethyl fumarate in a treatment for psoriasis. The 64-year-old patient did not have MS. She was taking a delayed-release form of dimethyl fumarate for psoriasis, developed progressive apraxia (speech problems), and was eventually diagnosed with treatment-related PML, although the initial diagnosis was atypical ischemic stroke. She eventually died from the condition.
It’s important to note that the medications this patient took were combined at a compounding pharmacy, not Biogen.
“If there is another case in a patient taking the currently recommended dose of Tecfidera, that would be interesting,” said Karen Blitz, director of the North Shore-LLJ Multiple Sclerosis Center in East Meadow, N.Y. in a statement in April. “Unless there is more data indicating a risk, I’m going to continue to use the drug and monitor white blood cell counts.”
Now that there has been a new case of PLM in a patient taking Tecfidera, although not fatal in this most recent case, Biogen points out that the drug label does warn that PML is a risk factor.
Of the new case, Catherine Falcetti, Biogen spokeswoman told MedPage Today, “It’s very similar to what we saw with the other case. It’s within the risk profile, and the risk-benefit ratio remains favorable.” She indicated the company does not have any plans at the moment to change the label, but encourages doctors to continue their treatment plans with Tecfidera and to monitor any indicates of prolonged severe lymphopenia in their patients.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?
