New Migraine Drug Approved By FDA
Pharmacia Corp.'s Axert (almotriptan) has been approved by the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults. Axert is an important new addition to available therapies for the 28 million Americans who suffer from migraine, according to a company news release.

Axert is available in 6.25 mg and 12.5 mg tablets. In clinical studies, the percentage of patients achieving a response (mild or no pain) two hours after treatment was significantly greater in patients receiving either dose of Axert than in patients who received placebo.

Leukemia Drug Receives FDA Approval
The U.S. Food and Drug Administration approved Gleevec (imatinib mesylate) by Novartis as an oral therapy for the treatment of patients with chronic myeloid leukemia (CML) in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy.

Gleevec is the first oncology drug to be developed with rational drug design, based on an understanding of how cancer cells function, according to a company news release. Gleevec addresses the genetic problem found in CML patients, which causes the uncontrolled proliferation of white blood cells. Gleevec blocks this process.

The FDA approval of Gleevec was based on three phase II open-label, single-arm studies that showed a major cytogenetic response in patients with advanced stages of CML. Patients with chronic phase CML after failure with interferon therapy achieved an 88% hematologic response and a 49% overall major cytogenetic response, both primary endpoints of the study, according to the company.

Study: OC Effective for Menstrual Symptoms
Yasmin (drospirenone 3 mg and ethinyl estradiol 0.030 mg), a low-dose, monophasic oral contraceptive from Berlex Laboratories, provides relief from some of the most common physical and emotional symptoms associated with the menstrual cycle, including negative mood, water retention and increased appetite, according to results of a study presented at the American College of Obstetricians and Gynecologists 2001 Clinical Meeting in Chicago in May.

Yasmin is the only oral contraceptive to contain drospirenone, a progestin that is different from progestins in other currently available oral contraceptives. Dros-pirenone exhibits anti-mineralocorticoid activity, which prevents the action of the hormones responsible for sodium and water retention, according to a company news release.

FDA Approves Combo Hepatitis A and B Vaccine
Twinrix (hepatitis A inactivated and hepatitis B [recombinant] vaccine) by GlaxoSmithKline Biologicals has received approval from the U.S. Food and Drug Administration for the prevention of hepatitis A and hepatitis B in adults.

The FDA reviewed data from 11 clinical trials involving more than 1,500 patients worldwide. Patients received three doses of Twinrix over a six-month period. A study in the United States compared Twinrix to separate vaccines for hepatitis A and hepatitis B and found that patients receiving Twinrix had antibody responses similar to those of patients receiving the separate vaccines over the same time period.

Each year, up to 500,000 Americans are infected with hepatitis A or hepatitis B and many of them have no known risk factors. Hepatitis A and hepatitis B are the most common vaccine-preventable diseases in travelers, according to a company news release.