FDA Approval of Drug Gives Diabetics a New Choice
The Food and Drug Administration on Tuesday approved Bristol-Myers Squibb’s new diabetes drug Glucovance, which may help patients control their blood sugar better than some existing pills.
The approval comes at an opportune moment for Bristol-Myers, which next month will lose patent protection on its top diabetes drug, Glucophage. The pill, with $1.3 billion in sales last year, is the company’s top-selling medicine.
For the record:
12:00 a.m. Aug. 3, 2000 For the Record
Los Angeles Times Thursday August 3, 2000 Home Edition Part A Part A Page 3 Metro Desk 2 inches; 61 words Type of Material: Correction; Wire
Drug approval--An Associated Press story Wednesday on the Food and Drug Administration’s approval of a new Bristol-Myers Squibb diabetes drug, Glucovance, incorrectly identified the drug’s makeup. Glucovance is a combination of another diabetes drug made by the company, Glucophage, and the generic diabetes pill glyburide. The story incorrectly said it was Glucophage and metformin, which is the generic name of Glucophage.
Glucovance, which is a combination of Glucophage and a generic diabetes pill Metformin, is intended as a therapy for patients with Type 2, or adult-onset, diabetes. Analysts estimate Glucovance could generate annual sales of at least $900 million.
A Bristol-Myers-funded study of 800 patients, presented at the American Diabetes Assn. meeting in June, found that Glucovance worked better at reducing patients’ blood sugar than either Glucophage or Metformin alone.
The company did not conduct any tests of Glucovance against two newer diabetes drugs--SmithKline Beecham’s Avandia and Eli Lilly’s Actos. Lilly sells Actos in partnership with the Japanese firm Takeda Pharmaceuticals.
More than two-thirds of the patients in the study who received Glucovance achieved ADA-recommended blood sugar goals. “Glucovance represents a new approach to managing Type 2 diabetes,” said Richard J. Lane, president of Bristol-Myers’ worldwide medicines group. “It is our hope that the introduction of this novel agent could change the treatment paradigm for the more than 15 million patients in the U.S. with this condition.”
The most common side effects of Glucovance are diarrhea, nausea and upset stomach. Less frequently, symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness or hunger, may occur.
In rare cases, Glucovance may cause lactic acidosis, which can be fatal in up to half of cases. Lactic acidosis occurs mainly in people whose kidneys are not functioning properly. Patients should not take the drug if they have kidney problems, the company said.
