Skip to main content

Gilenya, First Oral MS Drug, Gets FDA Nod

Once-Daily Capsules Cut MS Relapses, Delay Progression
 
By Daniel J. DeNoon
WebMD Health News
 
Sept. 22, 2010 -- The FDA today approved Novartis' Gilenya, the first oral drug for multiple sclerosis (MS). Gilenya (formerly spelled Gilenia, generic name fingolimod) last June received the overwhelming approval of an FDA expert advisory panel.

Gilenya treats the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised.

In MS, white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, 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. Novartis will 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.

Gilenya 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, Gilenya can have severe toxicity. In clinical trials, side effects linked to Gilenya included:

    * Elevated liver enzymes
    * Macular edema (swelling of the central portion of the retina, causing distorted vision)
    * Elevated blood pressure
    * Shortness of breath
    * Bronchitis
    * Diarrhea
    * Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommended that patients be required to receive their first dose under medical supervision).

Two fatal herpes infections occurred in MS patients treated with Gilenya at 2.5 times the 0.5-milligram dose for which Novartis is seeking approval.

But overall, the drug's benefits outweighed its risks among the more than 2,600 MS patients who took the drug in clinical trials.
Labels:

Comments

Post a Comment

Popular posts from this blog

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...
Post a Comment
Read more

Evidence for Atypical Antipsychotic Drugs Called into Question

Despite massive advertising and booming prescriptions, use and sales, the new atypical antipsychotic medications such as Seroquel and Abilify – used to treat schizophrenia , bipolar disorder, depression and other illnesses – lack sufficient evidence to support their widespread and generalized usage. This according to a new study out of the Stanford University School of Medicine and University of Chicago. In the past decade, atypical antipsychotics have rocketed past many commonly prescribed, but older antidepressant and other psychiatric medications. Although initially touted as having few side effects, followup studies have found that atypical antipsychotics have serious side effects, including significant weight gain that can lead to diabetes and heart disease. “Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, M.D., Ph.D., a Stanford associate pro...
Post a Comment
Read more

In India, there is no separate guidance on pregnancy reporting

How will we conclude that the subject is illiterate? Dr Prakash Atlam The guidelines don’t use the term illiterate. Their focus is subject’s ability to read and/or write. Schedule Y treats anyone who is unable to read or write in the same way. See the excerpt below. If the subject or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form. While designing a protocol we found that there are high likely chances of worsening of some of the symptoms. Do we have to wait for these to happen and report it as SAE or in case we define them in the protocol upfront then can we prevent from expediting reporting it as SAE? Om Please see suggested guidance from ICH. Exemption from reporting such events would require prior agreement with regulatory authorities. ICH E3 12.2.2 Display of Adverse Events: All adverse events occurrin...
Post a Comment
Read more