OmnitropeTreatment for Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency
FDA Defers Decision on Omnitrope Application
VIENNA, Austria, September 2, 2004 -- Sandoz has received notice from the US Food and Drug Administration (FDA) that the agency is unable to reach a decision on whether to approve an application for the marketing of the recombinant DNA human growth hormone Omnitrope.
According to the FDA letter issued to Sandoz, the agency has completed its review of Omnitrope and did not identify any deficiencies in the application. However, the agency stated it had been unable to reach a final decision on the application due to uncertainty regarding scientific and legal issues.
"We appreciate the constructive consultations held with the agency, and believe we have submitted complete and thorough data to support marketing approval for Omnitrope," said Dr. Alexander Berghout, Head of Clinical Development and Regulatory Affairs, Biopharmaceuticals, Sandoz. "We believe it is important for patients and healthcare providers that cost-effective follow-on biologics like Omnitrope become available as safe and effective therapeutic alternatives."
Sandoz acknowledges that the approval of most follow-on biologics in the US will require new legislation to ensure that the FDA has the authority to fulfill its mission of ensuring the safety and efficacy of every approved medicine. The company supports a transparent public process to help identify an appropriate regulatory pathway for follow-on biologics with an emphasis on ensuring patient safety while protecting the legitimate intellectual property rights of innovator companies.
"Technologies to make medicines, particularly biologics, have progressed rapidly during the last 20 years," Dr. Berghout said. "It is critical that advancements be made in regulatory requirements to improve patient access to high-quality, cost-effective alternatives to branded products that have lost patent protection."
Sandoz believes that rigorous scientific criteria should be applied with the highest standards, but without unnecessary or unethical duplication of pre-approval studies or clinical trials and without wasting resources that are needed to invest in continuous innovation. Generics and follow-on proteins are an important part of the tool kit that physicians must use to provide high-quality and cost-effective healthcare for their patients.
Sandoz, a Novartis company, is a world leader in generic pharmaceuticals and develops, manufactures and markets these medicines as well as pharmaceutical and biotechnological active ingredients. Decades of experience and profound know-how make Sandoz a renowned partner in its pharmaceuticals, biopharmaceuticals and industrial products franchises. Sandoz employs around 13,000 people worldwide and posted sales of USD 2.9 billion in 2003.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80,000 people and operate in over 140 countries around the world.
Posted: September 2004
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