Physician Views: Sanofi's Lemtrada finally approved in the US – how will neurologists use the multiple sclerosis therapy?
Two years after it was first submitted for approval with the FDA, Sanofi's multiple sclerosis treatment Lemtrada was green-lighted for launch in the US earlier this month.
The product featured notably during Sanofi's investor day last week and continues to intrigue, given the combination of its impressive efficacy and notable side-effect profile.
While EU regulators were less cautious in their appraisal of Lemtrada (approving for use in first-line patients if physicians see fit), the FDA approved a label that limits use to the third-line setting.
Patients who see their MS progress beyond two lines of therapy still represent a significant share of the relapsing market, equal to around 50 percent of all patients, noted Sanofi management last week (ViewPoints: Sanofi's Lemtrada flies the flag for patient power; can it carve a niche in the US multiple sclerosis market?).
The French company argues that uptake among European physicians is encouraging (a trend supported by a pre-launch Physician Views poll run by FirstWord last year; Physician Views Poll Results – Sanofi's new multiple sclerosis treatment Lemtrada to be used more widely than expected?), with a lack of significant revenue to date illustrative of the protracted reimbursement processes that are typical of the region. Consensus forecasts sourced from Bloomberg indicate global sales in 2018 of around $365 million.
With these factors in mind, coupled with reportedly strong US patient advocacy support to influence the FDA's assessment of Sanofi's drug, we are polling US based neurologists to ascertain how they expect to prescribe Lemtrada. Specifically we are asking them.
The product featured notably during Sanofi's investor day last week and continues to intrigue, given the combination of its impressive efficacy and notable side-effect profile.
While EU regulators were less cautious in their appraisal of Lemtrada (approving for use in first-line patients if physicians see fit), the FDA approved a label that limits use to the third-line setting.
Patients who see their MS progress beyond two lines of therapy still represent a significant share of the relapsing market, equal to around 50 percent of all patients, noted Sanofi management last week (ViewPoints: Sanofi's Lemtrada flies the flag for patient power; can it carve a niche in the US multiple sclerosis market?).
The French company argues that uptake among European physicians is encouraging (a trend supported by a pre-launch Physician Views poll run by FirstWord last year; Physician Views Poll Results – Sanofi's new multiple sclerosis treatment Lemtrada to be used more widely than expected?), with a lack of significant revenue to date illustrative of the protracted reimbursement processes that are typical of the region. Consensus forecasts sourced from Bloomberg indicate global sales in 2018 of around $365 million.
With these factors in mind, coupled with reportedly strong US patient advocacy support to influence the FDA's assessment of Sanofi's drug, we are polling US based neurologists to ascertain how they expect to prescribe Lemtrada. Specifically we are asking them.
- To what percentage of patients with relapsing forms of MS would you expect to prescribe Lemtrada 12 months post-launch?
- Based on your knowledge of the product, in what line of therapy (irrespective of labelling for the drug) do you think use of Lemtrada is best suited?
- What barrier to usage do you expect Lemtrada's specified use in third-line patients will provide?
- Would you consider prescribing Lemtrada in an off-label (i.e. earlier than third line) capacity?
- At peak, to what percentage of relapsing MS patients would you expect to prescribe Lemtrada?
