Novartis Updates Drug Labels

Story first appeared on Reuters.
Novartis International AG / Novartis updates US label on GilenyaR following discussions with the FDA . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

• Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States.
• Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment.
• Update to label marks the conclusion of discussions initiated in December 2011.

Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for GilenyaR (fingolimod). These changes are an attempt to alleviate any unrest about their drug related to recent reports of death, according to Washington DC Personal Injury Lawyers.

The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The update marks the conclusion of discussions initiated in December 2011.

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted.

As of February 2012, approximately 36,000 patients have been treated with Gilenya in clinical trials and in the post-marketing setting.

Gilenya represents an important treatment option for relapsing forms of MS. Choosing appropriate patients for Gilenya therapy and patient safety is essential.


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Novartis Pill Responsible for Fatalities in Patients

Story first appeared in the Wall Street Journal

Novartis AG Friday said a patient treated with its multiple-sclerosis pill Gilenya has been diagnosed with a rare and often fatal brain disease.

The Swiss drug maker said the patient, whose identity hasn't been disclosed, had been previously treated with another MS drug, Tysabri, co-marketed by Biogen Idec Inc. and Elan Corp. PLC, which has been already associated with progressive multifocal leukoencephalopathy, or PML.

The current assessment is that Tysabri is the drug most likely associated with this case of PML. However, a contribution of Gilenya to the evolution of this case can't be excluded.

The development comes at a critical time for Novartis's Gilenya, whose safety profile has recently come into question after the death of one person in the U.S. last autumn within 24 hours of starting treatment. Heart problems in some patients were also reported.

The European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago, is expected to issue a decision on the safety of the medicine on April 20 following an in-depth review.  Washington D.C. Products Liability Lawyers are following the case.

Novartis said it doesn't know of any confirmed PML cases in patients treated with Gilenya, also known as fingolimod, who hadn't previously been treated with Tysabri. The company said details on the case are being submitted to health authorities.

The development has to be taken seriously, but the question is more whether this is a trend, with a second or even third case coming up in the next few weeks. The timing is unfortunate, with the pill's risk-profile under investigation and certainly, there was no need for a second problem.

Gilenya, which is currently the only oral multiple-sclerosis treatment on the market, has so far been approved in more than 55 countries, with more than 25,000 patients having been prescribed it.

Industry analysts have said it could generate sales of at least $1 billion a year, helping to offset lost revenue caused by the expiry of Novartis' top-selling heart drug Diovan.

Europe's drug regulator in January launched an in-depth review of the drug's benefits and risks, and recommended that doctors closely monitor the hearts of patients after they have been given the first dose of the drug. The final product liability verdict is likely to have a big impact on the product's prospects and investor sentiment to Novartis shares.

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Treatment Eases Involuntary Laughing, Crying Tied to Alzheimer's, MS

Business Week

Involuntary crying or laughing can be a common symptom in patients with certain neurological disorders, such as Alzheimer's, multiple sclerosis or amyotrophic lateral sclerosis (ALS).

However, a combination of drugs could be the first effective long-term treatment for the problem, researchers say.

The new treatment for curbing these unwanted crying/laughing episodes -- known to doctors as "pseudobulbar affect" or PBA -- uses two drugs, dextromethorphan and low-dose quinidine.

Early indications are that the two drugs do reduce the incidence and severity of PBA episodes and improve quality of life.

"There's no FDA-approved therapy for pseudobulbar affect," noted study lead author Dr. Erik P. Pioro, director of the section for ALS and related disorders at the Cleveland Clinic in Ohio, and a member of the American Academy of Neurology (AAN). "The off-label medications that are being used have their own set of side effects and problems. So from a medical and patient care point of view, it would be very worthwhile to have an approved medication that is both safe and effective," he said.

Pioro presented the findings at a press conference held earlier this week at the AAN's annual meeting in Toronto.

The study authors note that PBA typically manifests in patients with an underlying neurological illness, including those with multiple sclerosis (MS), ALS (also known as Lou Gehrig's disease) or Alzheimer's, as well as patients suffering from other dementias and/or brain infections and injuries.

Pioro said that conservative estimates put the number of Americans with PBA at close to 2 million, although he said the figure might actually be as high as 6 million to 7 million.

Dextromethorphan is a common medication and a principle ingredient of standard cough syrup, according to Dr. Lily K. Jung, medical director of the neurology clinic and chief of neurology at the Swedish Medical Center in Seattle. The drug has previously been shown to have a "significant" effect upon parts of the brain responsible for behavioral control, she said at the press briefing.

Jung, who did not take part in the study, noted that quinidine is sometimes used to treat heart rhythm abnormalities. When combined at very low doses with dextromethorphan, it appears to help prolong that drug's usefulness.

In the study, Pioro and his colleagues enlisted 283 patients with PBA in an initial drug trial, during which some patients received one of two dosage levels of the two medications, while others received placebos.

After a two-week break, this was followed by a second phase involving 253 of the original study participants.

During the study's second part, patients were exposed to daily doses of the two-drug regimen for 12 weeks.

Pioro and his colleagues observed "significant improvement" among all the patients -- particularly among those who had not been exposed to the drug combo until the second part of the study.

Overall, Pioro noted that "there was an improvement of probably about 30 to 40 percent of symptoms" on average.

"Hopefully, we will soon have a very effective approved therapy to help these patients, which is important because this problem is probably much wider and more prevalent than we realize," he said.

"Very often patients who have this can be mistaken for having depression," Pioro explained. "But they're not depressed. Pseudobulbar affect is actually incongruent usually to the inner mood that the person has. So it can generate a lot of misconceptions. And patients will often be stigmatized, if you will, as a result."

Jung agreed. "This is exciting," she said, "because pseudobulbar affect can be so significantly socially disabling."

Still, further investigation into the drug combo's potential is warranted, since Pioro's study was relatively small. "Obviously more studies need to be done in larger groups of patients," Jung cautioned. "And testing for benefit should be done with other validated measures."

In Missouri, seek counsel from a St. Louis Neurologist.

FDA Approves MS Drug

CNN

The second-to-last time EJ Levy was at Disney World, she used a scooter to navigate the enormous park. Her legs were weak and she suffered from foot drop caused by multiple sclerosis. That was 4½ years ago. On her most recent trip, a few months ago, Levy walked the entire time, thanks in part to a drug approved by the FDA on Friday.

The FDA says the drug, Ampyra (generic name dalfampridine, formerly known as fampridine), is the first MS therapy that is taken orally and the first of its kind to receive FDA approval. It is designed help people with any type of MS improve their walking speed.

The prime of her life

In 2002, Levy was in her 30s and an active hiker and skier with a job on Wall Street and later in San Francisco, California. But her life took a turn when she started stumbling, falling down and dragging her right leg. Her doctor's diagnosis? Secondary Progressive Multiple Sclerosis, a less common form of MS and, as the name implies, one that usually plagues people with the disease after its initial course.

The National Multiple Sclerosis Society defines MS as a "chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves." Symptoms of MS include extreme fatigue, difficulty walking, problems with memory and heat sensitivity.

The most common form of MS is relapsing-remitting, in which people have acute attacks followed by periods of remission. In secondary progressive, however, the disease worsens steadily and there are no acute flare-ups. People with relapsing-remitting may later develop secondary progressive MS.

Levy says she lived in the same building as her parents at one point because she needed them to help take care of her. She says she mostly stayed at home, and when she did venture out she usually walked only a block or two with a cane. She relied on a wheelchair for longer distances.

She says she realized she would eventually be unable to walk. "I was scared of being in a wheelchair. I was scared of getting worse and worse. I had traveled around the world before I got sick, I was super independent," Levy says.

Trying things out

After exhausting the usual MS treatments -- and developing intolerable side effects -- Levy also became frustrated that the treatments were primarily designed for people with the more common course of the disease, and not the secondary progressive course.

Levy's neurologist then discussed the possibility of trying 4-aminopyradine -- a version of the same drug the FDA approved Friday that was available only through compounding pharmacies. Just three days after taking the drug, Levy was able to walk unassisted.

"I never thought I could put my cane away for good," she said.

Now she hopes the same drug that helped her will be able to help other people. She addressed an FDA advisory panel late last year and recommended approval of it.

"It's about quality of life," Levy says.

How it works

Two phase III clinical trials of Ampyra showed 35 and 43 percent of patients experienced, on average, a consistent improvement in their walking speed, increasing it by about 25 percent.

According to the National Multiple Sclerosis Society, even a modest improvement in walking ability could mean that thousands of people could benefit from the drug.

Dr. John Richert, executive vice president of Research & Clinical Programs at the National Multiple Sclerosis Society, says the drug can be used by most people with MS. However, the drug is not for people with a history of seizures or people who have moderate to severe kidney disease.

Richert says approval means patients can now skip the compounding pharmacy and get a consistent, exact dosage in a guaranteed time-released formula, which would lower the risk of getting a toxic dose instead of a therapeutic dose.

"It's likely that further study and clinical practice may help to determine the extent to which the drug may impact other functions, and may also provide hints as to which patients are most likely to respond positively to the therapy," Richert said.

He added that the drug would not help nerves that have been destroyed and emphasized that people should try the drug to see if it works for them.

Ampyra may not work for everyone. "Like any medication, people will have different responses, so they should talk to their doctors about whether it's appropriate to start therapy on Ampyra," according to a spokesperson from Acorda, Ampyra's manufacturer.

Moving with MS

Today, Levy is doing well. She established the not-for-profit organization MS Hope for a Cure, and in three years the organization has raised $1.8 million for research and programs to help people living with MS.

She has also completed several five-mile hikes. But she says she is always conscious of where she steps. She says she occasionally has some weakness in her leg, but that she is thankful for every day: "I don't ever take jumping out of bed for granted."