Physician Views: Sanofi secures EU approval for its multiple sclerosis treatment Lemtrada – how will neurologists use it?
With Sanofi securing European approval for its multiple sclerosis therapy Lemtrada last week, neurologists in the region have at their disposal a new option in the treatment armoury.
A number of key opinion leaders (KOLs) have previously argued to FirstWord that Lemtrada is the most efficacious MS therapy available, but that usage will be limited by a more prominent safety profile versus other treatments - see FirstWord Therapy Trends: Multiple Sclerosis - KOL Insight.
This has driven some KOLs to suggest that Lemtrada could be used primarily as a last line of treatment, although others have said that given its potential to 'switch off' relapses for a year or two after initial administration, neurologists may also find usage of Lemtrada as a form of induction therapy. In approving a broad label for Lemtrada, the European Commission has at least opened the door for potential use across the MS treatment algorithm.
In addition to weighing up the efficacy and safety considerations of Lemtrada, a key factor in shaping uptake of Sanofi's product will likely be how the therapy is administered and how patients are subsequently monitored. The drug is administered initially daily (for about 7 hours) over a period of 5 days and then daily for a period of 3 days a year later. KOLs have noted that while this offers a certain level of convenience, monthly monitoring for certain patients, plus the logistics associated with administration taking place in a specialist setting, may preclude some usage of the product.
With the ABCR (Avonex, Betaseron, Copaxone and Rebif) therapies heavily entrenched and new oral therapies (Gilenya, Aubagio and Tecfidera – yet to launch in Europe) providing comparable efficacy with greater convenience, there is some suggestion among analysts that Lemtrada could compete quite closely with Biogen Idec's Tysabri. The latter represents another MS therapy that is recognised as being one of – if not the most – efficacious treatments available, but for which usage is limited by its side-effect profile. Biogen Idec has sought to improve the commercial opportunity for Tysabri via use of JVC testing, which is designed to limit the chance of patients using the drug developing PML.
This week's Physician Views poll will ask neurologists based in the 5EU (France, Germany, Italy, Spain and the UK):
A number of key opinion leaders (KOLs) have previously argued to FirstWord that Lemtrada is the most efficacious MS therapy available, but that usage will be limited by a more prominent safety profile versus other treatments - see FirstWord Therapy Trends: Multiple Sclerosis - KOL Insight.
This has driven some KOLs to suggest that Lemtrada could be used primarily as a last line of treatment, although others have said that given its potential to 'switch off' relapses for a year or two after initial administration, neurologists may also find usage of Lemtrada as a form of induction therapy. In approving a broad label for Lemtrada, the European Commission has at least opened the door for potential use across the MS treatment algorithm.
In addition to weighing up the efficacy and safety considerations of Lemtrada, a key factor in shaping uptake of Sanofi's product will likely be how the therapy is administered and how patients are subsequently monitored. The drug is administered initially daily (for about 7 hours) over a period of 5 days and then daily for a period of 3 days a year later. KOLs have noted that while this offers a certain level of convenience, monthly monitoring for certain patients, plus the logistics associated with administration taking place in a specialist setting, may preclude some usage of the product.
With the ABCR (Avonex, Betaseron, Copaxone and Rebif) therapies heavily entrenched and new oral therapies (Gilenya, Aubagio and Tecfidera – yet to launch in Europe) providing comparable efficacy with greater convenience, there is some suggestion among analysts that Lemtrada could compete quite closely with Biogen Idec's Tysabri. The latter represents another MS therapy that is recognised as being one of – if not the most – efficacious treatments available, but for which usage is limited by its side-effect profile. Biogen Idec has sought to improve the commercial opportunity for Tysabri via use of JVC testing, which is designed to limit the chance of patients using the drug developing PML.
This week's Physician Views poll will ask neurologists based in the 5EU (France, Germany, Italy, Spain and the UK):
- To what type of relapsing remitting MS patients they would feel comfortable prescribing Lemtrada to?
- Based on current available therapies – which drug they would most likely switch patients to Lemtrada from?
- How they assess the convenience of Lemtrada's administration and monitoring requirements?
- To what percentage of all MS patients they anticipate prescribing Lemtrada to in 2 years time?
- By what percentage they estimate that their use of Tysabri has changed since JCV testing was introduced?
