Friday July 5, 9:51 am Eastern Time
AstraZeneca Gets First Market Approval for Iressa In Japan
Dow Jones Newswires
LONDON -- AstraZeneca (NYSE: AZN - News) PLC said Friday that its experimental cancer drug Iressa received approval for the treatment of inoperable or recurrent nonsmall- cell lung cancer from the Japanese government, making Japan the first country to license the drug.
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Iressa, or ZD1839, is the first in a new class of anticancer drugs, known as epidermal growth factor receptor inhibitors, to become commercially available. The drug was approved for a dosage of 250 milligrams a day.
The Japanese Ministry of Health, Labor and Welfare recently has re-engineered the new drug application review procedure, which historically has been seen as somewhat slower than other regulatory bodies world-wide.
The Iressa review, which is the fastest on record (besides that for an AIDS treatment), is among the first to benefit from the new system.
Iressa will be the first drug in the world to be simultaneously developed in Japan , the U.S. and Europe. It will be launched in Japan first.
AstraZeneca , based in London , is the second fastest-growing major pharmaceutical company and ranks first in the oncology market in Japan , the world's second-largest pharmaceutical market.
Nonsmall-cell lung cancer killed close to a million people world-wide in 2000 alone. Each year in Japan , there are 50,000 patients with the disease, of which 43,000 will die. The Japanese health ministry is forecasting an 80% increase in the incidence of lung cancer in Japan over the next 15 years. The world-wide market for lung cancer is currently worth about $1.6 billion, the majority of which is accounted for by nonsmall-cell lung cancer, and is scheduled to grow to $8 billion by 2011.
AstraZeneca anticipates full reimbursement for Iressa by the end of the third quarter. Product launch is expected in the second half of this year in the U.S. , while regulatory reviews in Switzerland and Australia are currently underway.
The first approval of Iressa is based on data from two pivotal Phase II trials -- IDEAL 1 and 2. Results from these studies confirm Iressa as an effective treatment for many patients with inoperable or recurrent advanced nonsmall-cell lung cancer, with an acceptable tolerability profile with the majority of side effects - diarrhea and skin rash -- reported as mild and reversible.
Iressa may have therapeutic potential in a broad range of common cancers. |
