Content about Eisai Co.

June 27, 2012

The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

The FDA announced the approval of Arena Pharmaceuticals' Belviq (lorcaserin hydrochloride), designed for use alongside reduced-calorie diets and exercise, for chronic weight management. Eisai will distribute the drug.

June 25, 2012

The U.S. pharmaceutical subsidiary of Eisai has promoted one of its executives.

WOODCLIFF LAKE, N.J. — The U.S. pharmaceutical subsidiary of Eisai has promoted one of its executives.

Shaji Procida, who previously served as VP finance of Eisai Inc., has been appointed to serve as VP and CFO. In her elevated role, she will have oversight and responsibility for all of Eisai's financial operations in the United States and also will continue to serve as a member of the company's executive committee. Procida has worked at the drug maker since 1998.

March 26, 2012

A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said.

SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.


 

March 7, 2012

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

February 15, 2012

Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

PHOENIX — Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

According to a report released Wednesday by Wolters Kluwer Pharma Solutions' inThought research group, while Lipitor (atorvastatin) has 41% of the market share of all dispensed prescriptions of atorvastatin, it has 35% of the payer approval volume.

February 10, 2012

An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.

October 11, 2011

The Food and Drug Administration has accepted the first regulatory approval application for a generic version of a cancer drug made by Eisai.

HIGH POINT, N.C. — The Food and Drug Administration has accepted the first regulatory approval application for a generic version of a cancer drug made by Eisai.

Banner Pharmacaps announced Tuesday that it had filed for regulatory approval of generic bexarotene gelatin capsules in the 75-mg strength, a generic version of Eisai's Targretin, used to treat cutaneous T-cell lymphoma, or CTCL skin cancer. Under the Hatch-Waxman Act of 1984, once the drug is approved, Banner will be the exclusive supplier of a generic version of Targretin for 180 days.

August 30, 2011

A drug under late-stage clinical development by Eisai reduced the frequency of seizures in patients with epilepsy, according to trial results the drug maker presented Tuesday at the 2011 International Epilepsy Congress.

WOODCLIFF LAKE, N.J. — A drug under late-stage clinical development by Eisai reduced the frequency of seizures in patients with epilepsy, according to trial results the drug maker presented Tuesday at the 2011 International Epilepsy Congress.

July 29, 2011

The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.

The drug maker said the FDA issued a refusal to file letter in response to its application for perampanel, designed to treat partial-onset seizures in patients with epilepsy. In the letter, the FDA requested reformatting and reanalyses of some datasets, though Eisai said new studies probably were unnecessary.

June 7, 2011

Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

PITTSBURGH — Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

Mylan said that its subsidiary, Matrix Labs, has received final approval from the Food and Drug Administration to manufacture and market donepezil hydrochloride tablets in 5-mg and 10-mg strengths. The drug, a generic version of Pfizer and Eisai's Aricept, is used to treat dementia associated with Alzheimer's disease. Mylan said it will launch the product immediately.

June 2, 2011

The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

June 1, 2011

The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.

The FDA approved the company’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths, a generic version of Eisai and Pfizer’s Aricept. Donepezil hydrochloride tablets in the two strengths had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

June 1, 2011

Sandoz has launched generic versions of treatments for Alzheimer’s disease, the generic pharmaceuticals division of Swiss drug maker Novartis said Wednesday.

PRINCETON, N.J. — Sandoz has launched generic versions of treatments for Alzheimer’s disease, the generic pharmaceuticals division of Swiss drug maker Novartis said Wednesday.

Sandoz announced the launch of donepezil hydrochloride film-coated tablets and donepezil hydrochloride orally disintegrating tablets, which are generic versions of Eisai and Pfizer’s Aricept and Aricept ODT, respectively.

Donepezil hydrochloride film-coated and orally disintegrating tablets had sales of $2.3 billion in the 12-month period ended in March, according to IMS Health.

March 4, 2011

The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 2, 2011

The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.

January 25, 2011

Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

WOODCLIFF LAKE, N.J. — Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

Eisai said a phase-3 trial of the drug eritoran found the drug did not significantly reduce mortality in patients with the condition compared with placebo.

Severe sepsis causes about 215,000 deaths in the United States every year, with a mortality rate of about 30%.

November 14, 2010

The Food and Drug Administration has approved a new treatment for breast cancer, the agency...

SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for breast cancer, the agency said Monday.

The FDA approved Eisai’s Halaven (eribulin mesylate) for patients with breast cancer that has spread and who have received at least two chemotherapy regimens for the disease in its late stages. More than 200,000 women will be diagnosed this year with breast cancer, and nearly 40,000 will die from it, making it the second leading cause of cancer-related death among women, according to the National Cancer Institute.

October 24, 2010

The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals...

SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.

 

The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.

 

October 4, 2010

Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug...

NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.

Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.

September 16, 2010

The Food and Drug Administration has accepted for review a regulatory approval application for a...

WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

 

The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.

 

 

September 16, 2010

An advisory committee of the Food and Drug Administration has given a thumbs-down to a...

SAN DIEGO An advisory committee of the Food and Drug Administration has given a thumbs-down to a drug for treating obesity.

 

Eisai and Arena Pharmaceuticals said Thursday that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 to recommend against approval of the drug lorcaserin, saying clinical trial data did not adequately show that its benefits would outweigh its risks.

 

 

September 7, 2010

The generics division of Pfizer will sell an authorized generic version of a drug used...

PEAPACK, N.J. The generics division of Pfizer will sell an authorized generic version of a drug used to treat dementia.

 

Greenstone said Wednesday that it had agreed with Eisai to launch donepezil hydrochloride tablets, an authorized generic of Aricept. The drug is used to treat dementia related to Alzheimer’s disease. Eisai makes the drug under a partnership with Pfizer.

 

 

July 18, 2010

Eisai's new drug application for a drug designed as an adjunctive treatment of seizures associated...

June 30, 2010

Japanese drug maker Eisai will market a drug in the United States that was developed...