Aventis and Altana submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Alvesco (ciclesonide). The companies are seeking marketing approval of Alvesco for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older. Aventis and Altana signed an agreement in 2001 to jointly develop and market Alvesco in the US.
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 US clinical trials were nasopharyngitis, headache and upper respiratory tract infection.
With this submission Aventis delivers on its promise of four new product submissions in 2003. In June, the fast-acting insulin Apidra was submitted for approval in the EU and the US In December, Genta and Aventis submitted to the FDA the targeted cancer therapy Genasense for fast-track approval. In December, Aventis submitted the novel vaccine Menactra for protection against meningococcal meningitis in adolescents and adults aged 11-55 years to the FDA.
"After successful approval, these new products should complement our portfolio in key disease area - such as in diabetes, cancer and vaccines -, and have the potential to substantially contribute to our growth in the coming years," said Igor Landau, chairman of the Management Board of Aventis. "They will build on the successful performance of our current top-selling products, which we are continuing to expand into new indications and markets, as well as on our recently launched, younger products, such as the diabetes drug Lantus or the novel antibiotic Ketek."
"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."
"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 CEO 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."
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.
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.
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of € 17.6 billion, invested € 3.1 billion in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France.
Altana AG is an international pharmaceuticals and chemicals group with sales of about EUR2.6 billion and more than 10,000 employees worldwide.