Content about Eisai

March 27, 2013

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.

February 28, 2013

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

February 21, 2013

Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

WOODCLIFF LAKE, N.J. — Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

Valeant has bought the rights to Targretin (bexarotene) capsules and gel from Eisai for $65 million upfront, plus additional payments based on certain milestones. Under the deal, Eisai has transferred its regulatory approval application to Valeant, which will assume responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain rights to the drug outside the United States.

February 14, 2013

The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.

January 25, 2013

Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

NEW YORK — Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

December 11, 2012

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.

Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.

October 22, 2012

The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

The FDA announced the approval of Eisai's Fycompa (perampanel) tablets to treat partial-onset seizures in patients ages 12 years and older. Partial seizures are the most common type seen in people with epilepsy, according to the FDA.

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.

April 30, 2012

Eisai announced that Allen Waxman has joined the company.

WOODCLIFF LAKE, N.J. — Eisai announced that Allen Waxman has joined the company.

Waxman, who has worked at such companies as Kaye Schouler LLP and Pfizer, will serve as SVP and general counsel, where he will be responsible for leading the office of the general counsel and all legal matters for the company in the United States. Waxman also will be a member of the company's executive committee and also will join others in providing leadership for a number of global legal matters for Eisai.

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 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.

December 20, 2011

The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

BURLINGTON, Mass. — The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

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

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

HYDERABAD, India — Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai's Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer's disease. Both strengths will be available in 30-, 90- and 500-count bottles.

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 8, 2010

Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and...

SAN DIEGO Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and obese patients said the drug produced significant weight loss in patients with Type 2 diabetes.

 

Arena Pharmaceuticals and Eisai reported results of the one-year “BLOOM-DM” phase-3 trial of the drug lorcaserin, showing that a significant number of patients lost 5% to 10% of their weight by the end of the trial. Patients taking the drug also showed improvements in blood sugar levels, compared with those taking placebo.

 

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.