SerdolectTreatment for Schizophrenia
New Drug Application Submitted for Serdolect
Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia
COPENHAGEN, Denmark, Sept. 15, 2008-H. Lundbeck A/S announced today that the U.S. Food and Drug Administration (FDA) has completed the initial check for completeness and accepted the New Drug Application on Serdolect for the treatment of schizophrenia for review. This is the first NDA submitted in the US by Lundbeck, and it follows the launch of Serdolect in Europe, South and Central America, Asia, and the Middle East.
"We are very pleased that we have submitted an NDA for Serdolect as this will potentially provide patients suffering from schizophrenia in the US with a new treatment option," says Anders Gersel Pedersen, head of Lundbeck's drug development. He continues: "Schizophrenia is a serious disease and there is still a great need for improved therapies to offer patients. Patients suffering from schizophrenia frequently switch drugs, either due to side-effects or lack of response."
Serdolect is an effective antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extrapyramidal symptoms (EPS). The lack of sedative and anticholinergic effects is believed to benefit cognition, which often is impaired in patients suffering from schizophrenia.
The efficacy, tolerability and safety of Serdolect has through daily clinical practise been confirmed in more than 70,000 patients. Serdolect's clinical and pharmacological profile indicates that the drug may improve their daily functioning and their quality of life and reduce the risk of relapse.
Serdolect derives from Lundbeck's in-house research and the company holds the global rights.
Schizophrenia is a serious and often chronic mental disorder affecting up to 1% of the world's population. In many patients the disorders start during late adolescence or early adulthood leading to severe changes in the patient's way of thinking and perceiving the outside world.
During the course of the illness, periods during which the patient is in an acute psychotic condition and suffering from definite hallucinations and delusions alternate with more stable periods during which the patient experiences a significant reduction in symptoms. However, even in stable periods, many patients have difficulty in establishing social contact, completing an education programme or holding a normal job. Schizophrenia patients may have significant difficulties in performing daily activities necessary for independent living. The occurrence of suicide and suicidal behaviour is a major burden for patients, families and society. Suicide is a leading cause of premature deaths among patients with schizophrenia. Schizophrenia is also associated with increased medical morbidity like respiratory or cardiovascular diseases which all contribute to a significantly lower life expectancy.
The disorder is often disabling and produces important emotional and financial hardship for the patient and the patient's family. Furthermore, schizophrenia causes a major economic burden to society, not only due to the direct treatment costs but also because of a reduced ability to work forcing many patients to claim disability or pensions.
The content of this release will have no influence on the Lundbeck Group's financial result for 2008.
Jacob Tolstrup Jens Harder Højbjerg
Director Media Relations Manager
+45 36 43 30 79 +45 36 43 28 33
Palle Holm Olesen
Head of Investor Relations
+45 36 43 24 26
Stock Exchange Release No 355 - 15 September 2008
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2007, the company's revenue was DKK 11 billion (approximately EUR 1.5 billion or USD 2.0 billion). The number of employees is approx. 5,300 globally. For more information, please visit www.lundbeck.com.
Posted: September 2008
- Lundbeck provides update on NDA for Serdolect for the treatment of schizophrenia - May 20, 2009
- FDA Advisory Committee provides opinion on Serdolect for the treatment of schizophrenia - April 8, 2009