Physician Views snap poll: Has Biogen's Tecfidera life-cycle management strategy got legs?

Biogen and its partner Alkermes this week announced positive head-to-head data for a 'next generation' version of the blockbuster multiple sclerosis therapy Tecfidera. 

Diroximel fumarate - which will be branded as Vumerity if approved - showed superior gastrointestinal tolerability versus Tecfidera. The positive result is particularly important as Tecfidera, which generated global sales of $1.2 billion during the second quarter, is also facing a number of patent challenges.

To get a better understanding of what impact Vumerity could have on the multiple sclerosis market if approved, we are snap-polling US and EU3 (France, Germany and the UK) based neurologists about the new data…    

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Q. Positive top-line results have been announced for EVOLVE-MS-2; a large, randomised, double-blind, five-week, Phase III study of diroximel fumarate, an investigational, novel oral fumarate with a distinct chemical structure, for relapsing-remitting multiple sclerosis, compared to Tecfidera (dimethyl fumarate).

Diroximel fumarate was statistically superior to Tecfidera on the study's pre-specified primary endpoint, with patients self-reporting significantly fewer days of key gastrointestinal (GI) symptoms with intensity scores ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS). 

The most common adverse events (AEs) reported were flushing, diarrhoea and nausea, at rates of 32.8%, 15.4% and 14.6% for diroximel fumarate versus 40.6%, 22.3% and 20.7% for Tecfidera.

The overall proportion of patients with AEs leading to study discontinuation was 1.6% for diroximel fumarate and 6.0% for Tecfidera. Of those, the proportion of patients who discontinued due to GI adverse events during the five-week treatment period was 0.8% for diroximel fumarate and 4.8% for Tecfidera.

Based on these data, approximately what percentage of the patients which you currently treat with Tecfidera would you consider switching to diroximel fumarate?

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Q. And based on these data, at what speed would you expect switching to occur?

Very slowly

Slowly

Moderately

Quickly

Very quickly

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Q. To what extent do GI-related AEs act as a barrier to your current use of Tecfidera as an initial treatment option for relapsing remitting multiple sclerosis?

Not a barrier

Somewhat of a barrier

Moderate barrier

Extreme barrier

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Q. To what extent do GI-related AEs act as a barrier to your current use of Tecfidera as an alternative treatment option for relapsing remitting multiple sclerosis patients switching from another therapy?

Not a barrier

Somewhat of a barrier

Moderate barrier

Extreme barrier

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Q. What impact would a superior GI tolerability profile have in driving your future utilisation of diroximel fumarate at the expense of Tecfidera even in a scenario where generic versions of Tecfidera were available at a significantly lower cost?

No impact

Slight impact

Moderate impact

Significant impact

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Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls.  However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.

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