PRINCETON, N.J., AND TOKYO, June 7 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the European Commission has granted marketing authorization for ABILIFY(R) (aripiprazole), an antipsychotic medication, for the treatment of schizophrenia.
"Receiving marketing approval for ABILIFY in 25 nations of the European Union marks a significant milestone for ABILIFY and for both companies, bringing an important medicine one step closer to the millions of people in Europe living with schizophrenia," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb.
"For patients with schizophrenia, ABILIFY has a unique pharmacology among the atypical antipsychotics and has demonstrated proven efficacy with a comprehensive tolerability and safety profile," said Tatsuo Higuchi, president & representative director, Otsuka Pharmaceutical Co., Ltd. "We are proud to have discovered ABILIFY and now be able to offer this important therapy in the European Union for people in need of treatment options of schizophrenia. It will also give Otsuka an opportunity to strengthen the foundations to introduce more of Otsuka's innovative medicines to people in Europe."
Otsuka Pharmaceutical Europe Ltd., the London subsidiary of Otsuka Pharmaceutical Co., Ltd., holds the marketing authorization for ABILIFY in Europe. Bristol-Myers Squibb and Otsuka will co-promote ABILIFY in several European countries.
Schizophrenia is a chronic and persistent brain disorder and one of the most severe common mental illnesses. There are millions of people across Europe living with schizophrenia. It occurs in all cultures and affects approximately one percent of the population worldwide. Schizophrenia interferes with a person's ability to think clearly, manage emotions, make decisions, and relate to others. This illness tends to manifest itself in early adulthood and is characterized by positive symptoms, such as hallucinations, delusions, and paranoia, as well as negative symptoms, such as social withdrawal and emotional flatness. While there is no cure for schizophrenia, it is a treatable illness.
ABILIFY(R) (aripiprazole) was approved by the U.S. Food and Drug Administration in 2002 for the treatment of schizophrenia. The efficacy of ABILIFY in schizophrenia was established by short-term and longer-term controlled trials. Since its approval, over 1.8 million prescriptions(1) have been written in the United States. In the United States, Abilify is available in 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets. For Europe, ABILIFY is manufactured in 5 mg, 10 mg, 15mg and 30 mg tablets.
Serious side effects can occur with any antipsychotic medicine, including ABILIFY. A rare but potentially fatal complex of symptoms referred to as neuroleptic malignant syndrome (NMS) has been reported. Another condition associated with antipsychotic medicines is called tardive dyskinesia (TD), a condition that can cause potentially irreversible involuntary movements.
Hyperglycemia, including some serious cases ranging from ketoacidosis to death, has been reported in patients treated with atypical antipsychotics. ABILIFY was not included in epidemiologic studies suggesting this risk; therefore the risk of hyperglycemia with ABILIFY is not known. However, there have been few reports of hyperglycemia in patients treated with ABILIFY. Patients should be appropriately monitored.
Some people taking antipsychotics have experienced orthostatic hypotension (lightheadedness or faintness caused by rising too quickly from a sitting or lying position).
As with other antipsychotic drugs, ABILIFY should be used cautiously if the patient has a history of seizures. Patients should not drive or operate heavy machinery until they are certain ABILIFY does not affect them adversely.
Before starting ABILIFY(R) (aripiprazole), patients should talk to their healthcare provider about any health problems and other prescription or nonprescription medicines they are taking.
In short-term clinical trials, the most commonly reported side effects compared to placebo (sugar pill) were: headache (32% vs. 25%), anxiety (25% vs. 24%), insomnia (24% vs. 19%), nausea (14% vs. 10%), vomiting (12% vs. 7%), sleepiness (11% vs. 8%), lightheadedness (11% vs. 7%), restlessness (10% vs. 7%) and constipation (10% vs. 8%).
The adverse events reported in a 26-week, double-blind trial comparing ABILIFY(R) (aripiprazole) and placebo were generally consistent with those reported in the short-term, placebo-controlled trials, except for a higher incidence of tremor: 9% for ABILIFY vs. 1% for placebo. In this study the majority of the cases of tremor were of mild intensity, occurred early in therapy (less than or equal to 49 days) and were of limited duration (less than or equal to 10 days). Tremor infrequently led to discontinuation (< 1%) of ABILIFY. In addition, in a long-term (52-week) active controlled study, the incidence of tremor for ABILIFY was 4%.
ABILIFY is available by prescription only. Patients should talk to their healthcare provider or pharmacist for more information. To learn more about schizophrenia and ABILIFY, including full prescribing information, please visit http://www.abilify.com/.
ABILIFY(R) is a registered trademark of Otsuka Pharmaceutical Co., Ltd.
About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in the development and commercialization of aripiprazole in the United States and in Europe. Aripiprazole was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka is a diversified health care company guided by its philosophy "Otsuka - people creating new products for better health worldwide" and dedicated to the research and development of innovative medical, pharmaceutical, and nutritional consumer products to improve the quality of human life. Otsuka has a diverse portfolio including central nervous system, cardiovascular, circulatory, gastro-intestinal, respiratory, dermatological, ophthalmologic, anti-cancer therapies, and is pursuing research in genomics and protein function. The Otsuka Pharmaceutical Group is comprised of 51 businesses and 22,000 employees around the world, earning total revenues of $4.3 billion annually.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
For more information and full prescribing information,
Visit Bristol-Myers Squibb on the World Wide Web at: http://www.bms.com/
Visit Otsuka Pharmaceutical Co., Ltd. at: http://www.otsuka.co.jp/
(1) IMS data
Bristol-Myers Squibb Company; Otsuka Pharmaceutical Co., Ltd.