MS Updates this week

Key events occurred this week in the MS therapy space. First is Merck Serono terminated development of cladribine in RRMS. Merck Serono had received tough responses from both the EMA and FDA, even though Movectro (cladribine) was approved for marketing in Russia and Australia. In February 2011, Merck Serono withdrew its application from the EMA for cladribine in MS and in March, the FDA gave a complete response letter to Merck Serono asking for more information on cladribine in Merck Serono. According to Merck Serono's press release this week, the FDA had indeed asked for more clinical trials and predictably Merck Serono was not unsure of the benefit given the changing landscape in the oral MS therapy space.

The other key development was the approval for use of JCV Ab status as a third risk factor in the EU Tysabri SmPC. This was predicted after the CHMP gave a positive opinion in April 2011 to this effect. The EC also approved additional 5 year marketing authorization for Tysabri in the EU. This is a great boost for Biogen Idec as it positions itself for a re-launch of Tysabri in the EU and US later this year.

Clearly there is a lot happening in this area as some drugs move out of the race and we expect results from more drugs in the later half of this year. BG-12, alemtuzumab, Laquinimod, teriflunomide are some of the other drugs in the pipeline which are expected to present results later this year. In fact some of these results can be expected starting July - August 2011. 

Future MS treatments

MS patients and caregivers have always been on the lookout for better and improved therapies for this disease. With a host of treatment options in the pipeline, there has never been so much activity in the new MS area since the return of Tysabri couple of years back. As per current announcements and estimates, the first wave of MS therapies is likely to hit pharmacies in late 2012. Actually, the wave already started with the launch of Gilenya last year. Key therapies which are likely to become available in the next couple of years include, teriflunomide, BG-12, Laquinimod and Lemtrada. Out of these BG-12 and laquinomd comes from existing MS companies, Biogen Idec and Teva respectively. Sanofi also has key players in this field with candidates  teriflunomide and Lemtrada (from Genzyme for cancer treatment).

Both BG-12 and teriflunomide have come out with positive data from first ph III studies. Further data is expected from both these compounds at the ECTRIMS meeting in October this year.

First post

This is the first post for the Neurology Update blog. Neurology is our focus of interest and we follow the latest events in Neurology to help ourselves and readers stay tuned to the latest in Neurology.

We will start by talking about Multiple Sclerosis (MS). MS treatment is undergoing a period of change with a variety of new drugs likely to apply for approval with health authorities. Key ones include, Teriflunomide, Laquinimod, BG-12, Cladribine, PEG-Avonex, Lemtrada (a.k.a Campath), Ocrelizumab and Daclizumab. These are just few of the drugs in late testing stages which will file for approval over the next few years. Our effort on this blog will be track the development and response to these drugs over time and develop better understanding of these new therapies.