You are here

New Drug Application Submitted to FDA For Asthma Drug Ciclesonide

BAD HOMBURG, Germany & STRASBOURG, France--(BUSINESS WIRE)--Dec. 30, 2003--ALTANA (NYSE:AAA) (FWB:ALT) and Aventis announced today that a new drug application (NDA) has been submitted to the US Food and Drug Administration (FDA) for Alvesco(R) (Ciclesonide). The companies are seeking marketing approval of Alvesco(R) for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older. ALTANA and Aventis signed an agreement in 2001 to jointly develop and market Alvesco(R) in the United States.

Alvesco is a new generation inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids are considered to be the foundation of asthma treatment, and they work by reducing inflammation - the underlying disease process - in the lungs and airways. The most frequently reported adverse events seen in Alvesco(R) US clinical trials were nasopharyngitis, headache and upper respiratory tract infection.

"Alvesco is an innovative new asthma therapy that, if approved, we believe offers an important treatment for patients with asthma," said Hans-Joachim Lohrisch, Member of the Board of ALTANA AG and Chief Executive Officer of ALTANA Pharma. "Alvesco is an important product in ALTANA's respiratory franchise, as it provides the company with a product with which to expand our presence in the US market and reinforce our commitment to providing innovative treatments for respiratory diseases."

"Alvesco represents our continued commitment to providing patients with innovative new therapies for the treatment of respiratory disease," said Frank L. Douglas, Executive Vice President for Drug Innovation and Approval and a member of the Management Board of Aventis. "Based on what we have seen in our clinical trials, we expect Alvesco to help fulfill an unmet medical need that still exists in the treatment of asthma."

Concurrent with the submission, Aventis has initiated a Phase IIIb, 12-month trial to further profile the safety and tolerability of high doses of Alvesco in adult patients with moderate to severe asthma. This trial will characterize the occurrence of lens opacity ocular events, as sometimes seen in patients who are treated with high doses of inhaled corticosteroids, including a small number of patients during one phase III Alvesco trial. The study was not a prerequisite for submission of the NDA to the US FDA.

About Asthma
Asthma is a chronic disease of the lungs and airways. It is characterized by wheezing, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. According to the American Academy of Allergy, Asthma and Immunology, more than 17 million Americans are currently estimated to have asthma.

Source: Altana and Aventis

Recent Headlines

Citrus, Berries, Broccoli Reduce Risk of Cancer and CVD
Changes in Antibiotic Recommendations for Children
Influences Gene Involved in Circadian Rhythms
‘The Perfect Drug for Trauma-Focused Psychotherapy’
Inrebic Reduces Symptoms by 50% in Some Patients
Novel Catheter-based Technology for Treating Acute Ischemic Stroke
Decision supported by data from more than 4,000 patients
Triggers the Body’s Own Natural Blood Flow Regulation