FDA assisting in withdrawal of Zinbryta (daclizumab) from the market

Biogen and AbbVie, on 2nd March 2018, decided to withdraw Zinbryta (daclizumab) from MS market primarily due to rising safety concerns of the product, including the concerns and reports of severe liver related disorders and immune related problems. Zinbryta was approved in the Multiple Sclerosis market and was available to the patients suffering from Relapsing form of Multiple Sclerosis.

The Food and Drug Administration body (FDA) in the US notified recently that they are working closely with the manufacturers to help ensure a well-organized withdrawal of Zinbryta from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment. The FDA further mentioned in the statement issued that no new patients will be initiated on Zinbryta or participate in the clinical studies related to Zinbryta and the company has begun notifying health care professionals and patients that the drug will be available for patients as needed until April 30, 2018.

FDA further mentioned that any questions or concerns about the withdrawal can be directed to the manufacturers’ service center at 1-800-456-2255 or the manufacturer’s website at www.zinbryta.com.

The suspension and withdrawal of Zinbryta (daclizumab) came on the back of “Urgent Review” announced by EMA, on March 2nd 2018, post the observance of 7 cases of serious inflammatory brain disorders in Germany which included encephalitis and meningoencephalitis, and also a case observed in Spain. A week after announcing the “Urgent Review”, EMA recommended immediate suspension and withdrawal of the product from the market based on 12 reports of serious inflammatory brain disorders observed worldwide resulting in 3 deaths as well.

Pharmascroll anticipates that the withdrawal of Zinbryta (daclizumab) would not have any major impact on the MS market as the product did not have a very strong sales uptake in the market. Also there are multiple drugs in MS market which have either similar or better benefit risk profile as compared to Zinbryta and hence the patients and physicians would have other options to look at, while transitioning the patients from Zinbryta.

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