Regulatory approval for Zinbryta and MabThera

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The US Food and Drug Administration has approved Biogen’s Zinbryta (daclizumab) for treating multiple sclerosis. Roche has received European approval for an injectable form of antibody therapy MabThera for chronic lymphocytic leukaemia.

Zinbryta is a long-acting injection that is self-administered by the patient monthly. “Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Dr Billy Dunn, director of the division of neurology products in the FDA’s Centre for Drug Evaluation and Research.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.

The effectiveness of Zinbryta was shown in two clinical trials. One trial compared Zinbryta and Avonex in 1,841 participants who were studied for 144 weeks. Patients on Zinbryta had fewer clinical relapses than patients taking Avonex. The second trial compared Zinbryta with placebo and included 412 participants who were treated for 52 weeks. In that study, those receiving Zinbryta had fewer relapses compared to those receiving placebo.

Zinbryta should generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. Because of the risks, Zinbryta has a boxed warning and is available only through a restricted distribution programme under a Risk Evaluation and Mitigation Strategy.

The boxed warning tells prescribers that the drug can cause severe liver injury, including life-threatening and fatal events. Health care professionals should perform blood tests to monitor the patient’s liver function prior to starting Zinbryta, monthly before each dose, and for up to six months after the last dose.

The boxed warning also highlights other important risks of Zinbryta treatment including immune conditions, such as inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy).
Additional highlighted warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal ideation.

The most common adverse reactions reported by patients receiving Zinbryta in the clinical trial that compared it to Avonex include cold symptoms (nasopharyngitis), upper respiratory tract infection, rash, influenza, dermatitis, throat (oropharyngeal) pain, eczema, and enlargement of lymph nodes.

The most common adverse reactions reported by patients receiving Zinbryta when compared to placebo are depression, rash, and increased alanine aminotransferase.

 

Drugmaker Roche has received European approval for an injectable form of antibody therapy MabThera for people with chronic lymphocytic leukaemia, the company is quoted in Reuters Health as saying.

The European Commission approved the injection for people with previously untreated and relapsed/refractory forms of the disease. “MabThera provides patients with significantly faster treatment administration and the opportunity to enjoy more time outside the clinical setting compared to intravenous delivery of the medicine,” CMO Sandra Horning said.

 

South Korea’s Samsung Bioepis said its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade has received final approval from European regulators, paving the way for its second product launch in Europe.

Reuters Health reports that Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said recently the biosimilar had been submitted for review in the US.

A relative latecomer to the industry, the report says Samsung Bioepis has found early success by beating rivals to market on some of the world’s top-selling drugs. It became the first company to launch a biosimilar version of Amgen’s Enbrel, another rheumatoid arthritis drug, in Europe.

Samsung Bioepis said minority shareholder and partner Biogen will be responsible for the commercialisation and distribution of its Remicade copy, called Flixabi in Europe.

The report says biosimilars, lower-cost copies of complex biotech drugs, are still relatively new but interest is growing quickly as firms such as Bioepis launch cheaper versions of blockbuster drugs.

FDA material
Full Reuters Health report
Full Reuters Health report


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