Merck also said on Wednesday it planned to withdraw cladribine from markets in Australia and Russia where it has been approved and is available under the name Movectro.

“Merck believes that data from ongoing clinical trials are very unlikely to address the (U.S. Food and Drug Administration’s) requirements,” it said, adding new trials would not justify the costs.

The potentially fatal infection, known as progressive multiform leukoencephalopathy (PML), occurs in an estimated 1.5 per 1,000 patients treated with Tysabri during months 25 to 36, the Food and Drug Administration said.

The FDA said it was the first time it had estimated the chances of PML for specific time intervals rather than providing a cumulative risk over years.

HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.

The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010.

Acorda said the FDA extended its review because it recently submitted new information on its risk evaluation strategy for the drug.

Acorda sent in the additional information following a meeting with an FDA panel on Oct. 14. The panel recommended that Fampridine-SR receive FDA approval.

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WASHINGTON — Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that questioned the safety and effectiveness of the company’s multiple sclerosis drug.

A panel of FDA advisers is scheduled to meet next week to vote on Acorda’s Fampridine-SR, which is designed to improve patients’ ability to walk. Multiple sclerosis affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems.

In briefing documents posted Friday, the FDA raised serious questions about whether the drug’s benefits outweigh its risks, which include seizures.

Acorda shares fell $4.76, or 21.4 percent, to close at $17.52 Friday. The company’s stock has traded between $14.42 and $29.27 in the past year.

Acorda conducted two trials tracking patients’ ability to complete a 25-foot walk. While both studies met their goal of showing that patients on the drug had a statistical improvement in walking ability compared with those on placebo, the actual time to complete the exercise did not improve.

“For these reasons, it appears the clinical meaning of the differences seen on the primary outcomes is in question,” according to the FDA review.

FDA scientists also noted an increased risk of seizures with the drug. The agency will ask its panel Wednesday whether the drug’s benefits outweigh its side effects, including both seizures and urinary tract infections.

The FDA is not required to follow the group’s advice, though it usually does.

Hawthorne, N.Y.-based Acorda stated in its own briefing documents that no evidence of seizures has been shown when the drug is given at the recommended 10-milligram dose. However, the company acknowledged that risks increase with higher doses.

“Patients and physicians should therefore be thoroughly informed about the risks of prescribing or taking higher than the proposed 10 mg dose,” the company said.

Deutsche Bank analyst Mark Schoenbaum said most specialists who treat the disease “do not seem phased,” by the drug’s seizure risk. In a research note to investors, Schoenbaum predicted the FDA panel will vote to approve the drug, but with a “black box” warning about seizures.

Acorda expects the FDA to complete its review of Fampridine-SR by Oct. 22.

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The German company’s US subsidiary EMD Serono has submitted a New Drug Application with the Food and Drug Administration for cladribine as a therapy for reducing relapses in people with MS. The drug was filed with the European Medicines Agency in July.

The filing is based on the two-year Phase III CLARITY trial, which revealed that 43% and 44% of patients with relapsing-remitting MS treated with cladribine, on a total dose of 3.5 mg/kg and 5.25 mg/kg respectively, had absence of disease activity, compared with 16% on placebo. Fereydoun Firouz, EMD Serono’s chief executive, said that if approved, short-course therapy with cladribine tablets “could transform the way people approach their treatment options, and meet an unmet need as an oral, disease-modifying drug”.

The company has not given any sales estimates for cladribine but analysts confidently predict blockbuster status for the compound which has been granted fast-track status by the FDA.

News of the filing came hours after Novartis had presented promising initial data from a two-year Phase III trial of its oral MS FTY720 (fingolimod). The Swiss company is planning regulatory submissions in the USA and Europe before the end of the year.

By Kevin Grogan

View full article here: http://www.pharmatimes.com/WorldNews/article.aspx?id=16669

WASHINGTON — The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn’t include risk information.

The warnings marked one of the first major actions by the FDA to crack down on Internet promotion, which is taking a bigger chunk of pharmaceutical marketing budgets because many people use search engines to find out about health problems.

The ads cited by the FDA typically come up as “sponsored links” when people type a disease name or product name into a search engine. Most of the world’s largest pharmaceutical companies were among the 14 that received FDA warning letters.

One letter went to Biogen Idec Inc. over its multiple sclerosis drug Tysabri.

The ads say “A Multiple Sclerosis Treatment That’s Different from the Others” or “Satisfied with your MS Medication or Looking for Something Different?” but don’t include any risk information, according to the FDA.

“Their casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution,” the FDA said in its letter to Biogen on March 26. The letter was posted on the agency’s Web site Friday.

Tysabri has been linked with a serious brain infection in several patients and is marketed under restrictions designed to reduce the risk of the side effect.

The company is working closely with the FDA to resolve the situation, said spokeswoman Naomi Aoki. She said the company takes its responsibility to communicate the risks and benefits of Tysabri “very seriously.”

Biogen’s ad includes a link to the Web site for the drug, which does contain the relevant risk information. The FDA said the link “does not mitigate the misleading omission of risk information from these promotional materials.”

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Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for COPAXONE® (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS).

The FDA’s approval follows a similar decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) in February 2009 under which 24 EU member states have mutually recognized an expanded label for COPAXONE® to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of MS.

Up to 85% of MS patients initially experience a single neurological event suggestive of MS, known as CIS, and it has been demonstrated that early treatment initiation delays conversion from CIS to clinically definite MS (CDMS). This expanded indication in the U.S. and Europe allows patients to begin treatment with COPAXONE® from the very early stages of the disease.

“COPAXONE®, the world’s leading MS disease modifying therapy, has demonstrated the ability to provide treatment benefits very early on, when patients present with a first clinical episode and have MRI features consistent with MS,” said Moshe Manor, Teva’s Vice President, Global Branded Products, “This milestone, along with the existing long-term safety and efficacy data, further position COPAXONE® as a cornerstone in MS treatment.”

The FDA granted approval after reviewing the results of the PreCISe study, which indicated time to development of a second exacerbation was significantly delayed in patients treated with COPAXONE® compared to placebo (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77; p=0.0005). The cumulative probability of developing the second attack during the three year study period was significantly lower in the COPAXONE® group versus the placebo group (24.7% vs. 42.9%).

COPAXONE® is the only RRMS treatment with prospective long-term data demonstrating 8 out of 10 patients adhering to therapy are still able to walk unassisted after 15 years of therapy and 22 years of disease duration.

An approval for an expanded label for COPAXONE® was also granted by the Australian Health Authority (Therapeutic Goods Administration, TGA) in December 2008.

About the PreCISe Study

The multinational, multi-center, prospective, double-blind, randomized, Phase III PreCISe study was conducted globally at 80 centers. It included a total of 481 patients presenting with a single clinical episode and MRI scans suggestive of MS over a period of up to three years. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either COPAXONE® 20mg/day or placebo as a subcutaneous injection and continued treatment for up to three years, unless a second exacerbation was experienced. Patients who experienced a second exacerbation continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to development of second exacerbation.

COPAXONE® (glatiramer acetate injection) was also shown to be well tolerated in the PreCISe study, with 84 percent of patients completing the three-year study period; this supports the safety and tolerability seen in RRMS patients treated with COPAXONE®.

A pre-planned interim analysis was performed on data accumulated from 81 percent of the three-year placebo-controlled study exposure. The PreCISe study demonstrated that the 25th percentile of number of days to second exacerbation more than doubled by COPAXONE® from 336 days to 722 days (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77) compared with placebo.

Moreover, there was a significant reduction in the number of new T2 lesions and in the number of T1-enhancing lesions in the COPAXONE® arm compared to the placebo arm, both at year one and year two magnetic resonance imaging (MRI) scans.

About COPAXONE®

COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

See additional important information at http://www.copaxone.com/pi/index.html

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.

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