The multiple sclerosis therapy Zinbryta (daclizumab) has been withdrawn from the market. The therapy, which was linked to Biogen Inc. (NASDAQ:BIIB) and AbbVie Inc. (NYSE:ABBV) was available in the EU and US markets. It has been linked to seven cases of serious inflammatory brain disorders in Germany. Three cases involved encephalitis, which according to the Food and Drug Administration spokesperson Sandy Walsh can result in permanent disability or even death. However, the FDA has confirmed that it is reviewing the uncertainties.
Global market withdrawals of this kind are relatively uncommon
Zinbryta was treating relapsing forms of MS. It was an alternative for many people who had unsuccessfully tried other medicines. It had been put on notice by the EM, which had consented to the need for further review in trying to reduce associated risks. It is also worth noting that the withdrawal of the therapy from the market by the companies was solely voluntary.
More often than not regulatory systems aims at ensuring the safety of the drug and its users before it can be made available. At the point of any approval, there is certainty of its safety according to co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, Dr. Caleb Alexander.
However, voluntary withdrawals of drugs from the market are very unusual. More often than not they come as an order from the FDA. Nonetheless, the executive vice president and chief medical officer at Biogen, Alfred Sandrock says, “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
Biogen pioneers the development of innovative therapies
Sandrock outlines that Biogen has the best interest of patients at heart. In case it is the pioneer in developing innovative therapies for patients living with neurological and neurodegenerative diseases. Apart from this, the company is the first to introduce the only approved treatment for spinal muscular atrophy.
Having been founded in 1978, Biogen’s mission and focus are clear. It has the highest portfolio of multiple sclerosis’ treatments and it aims at advancing neuroscience research programs in Alzheimer’s disease and dementia. All said and done, it has confirmed its commitment to collaborating with the regulatory authorities and healthcare providers in the withdrawal of product.