How scary is this scenario?
Most Neurologists Plan to Prescribe Oral Multiple Sclerosis Drugs, but Will Proceed with Caution
In a study published this week by Majestic Research, almost 60% of neurologists expressed unaided concern about the side effects/safety of oral MS therapies in development, including NVS’s Gilenia and MRK/EMD Serono’s oral cladribine. Despite their concerns, the vast majority of neurologists expect to prescribe these drugs if they are approved, as the new oral MS therapies are expected to be highly efficacious and more convenient for patients than available injectable therapies. Data from the study suggests that new orals will steal share primarily from multiple sclerosis market leaders, including BIIB’s Avonex and TEVA’s Copaxone.
Read more: Most Neurologists Plan to Prescribe Oral Multiple Sclerosis Drugs, but Will Proceed with Caution - FierceBiotech <shortened url
In the next article it lists some of the side effects linked to Gilenia in clinical trials.
I would really have to quiz any Neurologist who would recommend this oral drug over the existing inject able types, or better yet, diagnostic testing for CCSVI and possible angioplasty.
Claims have not been made that the oral drug is any safer, more effective, or has less side effects. The only plus that they have given is it’s “ease of administering”, which I can appreciate, as giving myself weekly injections was no picnic.
But it’s still a drug without a long history, so, even with a FDA Approval, those patients who decide to take the oral drug, are they not then patients in a non IRB approved, non sanctioned, mass distribution/prescription Drug Trial?
FDA Panel Votes to Approve Gilenia, First Oral MS Drug
June 10, 2010
- An FDA expert advisory panel today overwhelmingly recommended approval of Novartis's Gilenia, the first oral drug for multiple sclerosis (MS).
Gilenia (generic name, fingolimod) would be used for the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, liver, and eye toxicity and increased risk of infection. Patients must be closely monitored, the panel advised.
Gilenia is the first drug in its class. In MS, white blood cells attack the myelin sheathes that protect nerve cells. Gilenia keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph-node door.
Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections and cancers. Novartis has already promised to set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer term use.
Gilenia was invented as a new way to prevent rejection in kidney transplant patients. But at the necessary dosage, the drug was far too toxic. The dose that would be used to treat MS is five times lower than the lowest dose tested in the transplant studies.
Even at this dosage, Gilenia can have severe toxicity. The FDA panel recommended that Novartis be required to study whether even lower doses of the drug might be effective in MS.
Elevated liver enzymes
Macular edema (swelling of the central portion of the retina, causing distorted vision)
High blood pressure
Shortness of breath
Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommends that patients be required to receive their first dose under medical supervision).
Two fatal herpes infections occurred in MS patients treated with Gilenia at 2.5 times the 0.5 mg dose for which Novartis is seeking approval.
So far, no more cancers have been seen in MS patients taking Gilenia than in patients taking an inactive placebo.