BG 12, Part 2
In my first post on BG-12, I introduced the two major studies supporting its efficacy. No discussion of medication is complete without acknowledging the downsides, however. The most common side effects of BG-12 were flushing, headache, gastrointestinal upset, headache, and fatigue. Most of these side effects abated after one month. Most importantly, there were no deaths related to study treatment. There was no increase in infections, serious infections or cancers. The medication will likely be approved as a twice daily medication, and for some patients, having to remember to take a pill twice a day is not a small matter.
At this time, the medication still has to undergo review and approval by the FDA, something that could take most of 2012. Although I do not anticipate that there will be any unexpected hurdles from the FDA, this is always a possibility. Another oral drug, Cladribine, was rejected by the FDA in 2010, though there were more safety concerns with this medication than with BG-12.
In summary, BG-12 looks to be a very promising agent in preventing relapses and slowing disease progression in MS. It is an oral agent, and it appears superior to Copaxone, one of the oldest and most-established treatments in MS. Though it seems a certain percentage of patients will be unable to tolerate its side effects, no serious safety concerns have emerged with BG-12. Most MS neurologists are eagerly looking forward to the approval of BG-12 and expect that it will be one of our first-line agents in treating MS patients. Along with terifluomide this will mean that two new oral agents will soon be available for MS, if all goes according to plan, neither of which has any serious safety concerns thus far. Of course, this could always change when large numbers of people take the medication for a prolonged period of time. I expect these medications will be widely used in many MS patients, though they are far from a cure, and there will be many MS patients who will continue to have active disease on the medications, I suspect. The question of how to treat these patients will remain.
Nonetheless, these oral medications vastly expands the treatment landscape for MS patients and one wonders if 2012 will be the beginning of the end for the interferons and Copaxone. Alternatively, there may be a role for these oral agents to be combined with the older, injectable medications. This might allow MS to be attacked from two different angles. While it is certainly premature to speculate on the safety and efficacy of such combination therapies, there is no doubt that a new, exciting era in MS treatment has arrived. In addition to these oral agents, several new infusions have shown promising data. I will discuss these in future posts.