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Biogen reveals new data for MS therapies Tysabri and Vumerity

New data comes ahead of FDA decision on company's controversial Alzheimer’s drug aducanumab

Biogen has announced new data for its multiple sclerosis therapies Tysabri and Vumerity, including analyses of extended interval dosing (EID) and new real-world experience data.

The data, presented at the virtual American Academy of Neurology (AAN) annual meeting, includes quality of life benefits and analyses of EID with Tysabri (natalizumab).

Researchers analysed patient-reported data on 12 different domains on the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire to ‘better understand clinically meaningful quality of life benefits’ following Tysabri treatment.

They found that in people receiving Tysabri treatment or Roche’s Ocrevus (ocrelizumab) with baseline impairment, statistically significant improvements were observed in ten of 12 and eight of 12 Neuro-QoL domains, respectively.

The adjusted annualised rate of improvement was greater with Tysabri treatment compared with Ocrevus in 11 of 12 domains on the Neuro-QoL questionnaire.

Biogen added that the difference between the two therapies was statistically significant in favour of Tysabri in three domains, including satisfaction with social roles and activities, participation in social roles and activities and emotional and behavioural dyscontrol.

Another analysis of data found that Tysabri patients receiving EID or standard interval dosing (SID) had comparable real-world effectiveness on quantitative magnetic resonance imaging (MRI) outcomes.

An updated analysis of data from the TOUCH Prescribing Programme also demonstrated that EID was associated with an 88% reduction in the risk of progressive multifocal leukoencephalopathy (PML) compared to the approved every four-week dose.

In addition to the Tysabri data, Biogen also disclosed findings on the use of Vumerity (diroximel fumarate) in a real-world setting.

A retrospective analysis of data from December 2019 to August 2020 of 160 patients with relapsing MS found that the treatment discontinuation rate due to gastrointestinal side effects was 3.8%, with 88.6% estimated to still be on treatment at the end of the analysis and a 91.4% adherence rate.

“[This] data shows that the benefits Tysabri provides in terms of a patient’s quality of life are substantial and that the positive gastrointestinal tolerability profile of Vumerity can help people with relapsing MS continue with treatment, which is essential to delay its progression,” said Maha Radhakrishnan, chief medical officer at Biogen.

Aducanumab, which is currently under review with the US Food and Drug Administration (FDA), has not had a smooth journey on its way towards regulatory submission, with the data supporting the drug having been met with scrutiny from experts throughout the regulatory pathway.

In November, a panel of outside experts overwhelmingly voted no on a number of counts regarding the efficacy and evidence supporting the use of aducanumab in Alzheimer’s.

Biogen will receive a decision from the FDA for the intensely-watched drug by June after months of delay, although it's still not clear if the outcome will be a positive or disappointing one for the US biotech company.

Article by
Lucy Parsons

22nd April 2021

From: Research

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