Novartis: FDA grants priority review for Glivec® new drug application

28-Mar-2001

The US food and Drug Administration (FDA) has designated Glivec® (imatinab)* for priority review for possible use in the treatment of chronic myeloid leukemia (CML) in the blast crisis, accelerated, or chronic phases of the disease after failure of interferon-alpha therapy. Priority review status is granted by the FDA to products that are considered to be a potential therapeutic improvement over existing therapies. Actions taken on drugs given priority review are generally made within six months.

Novartis submitted the new drug application (NDA) for Glivec in the US on 27 February, 2001. Applications for approval have also been filed in the European Union, Switzerland and other countries; filing in Japan is expected shortly.

The filing application is based on study results from approximately 1 230 patients in 32 centers located in five countries. In fewer than three years since the initiation of clinical trials, Glivec has been studied in more than 5 000 patients in 30 countries. Based on early study results, the FDA designated Glivec "fast track status" during development for the indication of myeloid blast crisis phase in CML. In addition, Glivec was granted "orphan drug" designation in the US, European Union and Japan.

CML is one of the four most common types of leukemia. Worldwide, the disease occurs in one to two cases per 100 000 people per year and is responsible for 15-20% of all adult leukemias.

In clinical trials, Glivec has been generally well tolerated, with side effects including nausea, muscle cramps, edemas, skin rash, diarrhea, heartburn, and headache, which have been largely mild or moderate in intensity. Fewer than 3% of patients have experienced serious side effects such as the potential for liver toxicity, fluid retention syndrome, and hemorrhages.

This release contains certain "forward-looking statements" relating to the company's business, which can be identified by the use of forward-looking terminology such as "potential," "are generally made within six months" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of a new product, Glivec, for which the company has filed global marketing applications, and anticipated customer demand for such products. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of Glivec to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to unexpected regulatory delays, future clinical trial results, government regulation or competition in general, as well as factors discussed in the company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

https://www.chemeurope.com/en/news/2242/novartis-fda-grants-priority-review-for-glivec-new-drug-application.html