New FDA Approvals
These drugs recently were approved by the FDA:
• Metformin hydrochloride (HCl) (Glumetza) by Biovail Corp. and Depomed. The FDA has approved metformin HCl (Glumetza), a once-daily, extended-release formulation for the treatment of Type II diabetes.
Metformin is indicated for the control of hyperglycemia in metformin-responsive, stable, mild, nonketosis prone maturity onset diabetes (Type II), which cannot be controlled by proper dietary management, exercise, and weight reduction and when insulin therapy is not appropriate.
Patients should not take metformin if they have kidney problems, heart failure that is treated with medicine, or have a condition called metabolic acidosis, including diabetic ketoacidosis. Metformin can cause a rare condition called lactic acidosis.
The most common side effects of metformin include diarrhea, nausea, and upset stomach.
• Galsulfase (Naglazyme) by BioMarin Pharmaceutical. The FDA has granted marketing approval for galsulfase (Naglazyme), the first specific therapy approved for the treatment of mucopolysaccharidosis VI (MPS VI). BioMarin plans to launch galsulfase in the United States in July.
Clinical trials have shown that galsulfase provides clinically important benefits for MPS VI patients, specifically, improved endurance as demonstrated by the 12-minute walk test and three-minute stair climb. Galsulfase reduced the excess carbohydrates that are excreted in the urine of patients with MPS VI, an indication of enzymatic bioactivity.
Data from a Phase III clinical trial and extension study indicate that galsulfase was generally safe. The most common adverse events observed in clinical trials in galsulfase-treated patients were headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and otitis media. More than 95% of the infusion-related adverse events were considered mild or moderate and were easily managed. Infusion-related adverse events commonly included fever, chills/rigors, headache, rash, and mild-to-moderate urticaria. Severe reactions included angioneurotic edema, hypotension, dyspnea, bronchospasm, respiratory distress, apnea, and urticaria.
No patients discontinued galsulfase infusions for adverse events, and all patients that completed the double-blind portion of the trial continue to receive weekly infusions of galsulfase.
• New indication for peginterferon alfa-2a (Pegasys) by Roche. The FDA has approved peginterferon alfa-2a (Pegasys) for the treatment of chronic hepatitis B. Peginterferon alfa-2a is the only pegylated interferon approved for the treatment of chronic hepatitis B, including both variations of the virus — HBeAg-positive and HBeAg-negative chronic hepatitis B.
Peginterferon alfa-2a was approved in 2002 by the FDA for use alone and in combination with ribavirin (Copegus) for the treatment of adults with chronic hepatitis C. In February, Pegasys became FDA-approved as a therapy alone and in combination with ribavirin for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV whose HIV is clinically stable.
• New indication for budesonide (Entocort EC) capsules by Prometheus Laboratories. The FDA has approved the supplemental New Drug Application for the additional use of budesonide (Entocort EC) capsules for the maintenance of clinical remission of mild-to-moderate Crohn’s disease involving the ileum and/or the ascending colon for up to three months. Budesonide also is indicated for the treatment of mild-to-moderate Crohn’s disease involving the ileum and/or the ascending colon.
• New indication for infliximab (Remicade) by Centocor. The FDA has approved infliximab (Remicade) to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. Infliximab has also been approved in the treatment of such inflammatory diseases as Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It was first approved in 1998 for Crohn’s disease.
• New indication for fondaparinux sodium, injection (Arixtra) by GlaxoSmithKline. The FDA has approved the supplemental New Drug Application for fondaparinux sodium in the prevention of venous thromboembolism (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.
Fondaparinux sodium already is approved for the prevention of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing surgery for hip fracture (including extended prophylaxis), knee replacement, and hip replacement. Additionally, fondaparinux sodium is indicated for the treatment of acute DVT when administered in conjunction with warfarin sodium, and for the treatment of acute PE when administered in conjunction with warfarin sodium, when initial therapy is administered in the hospital.
Metformin hydrochloride (HCl) (Glumetza) by Biovail Corp. and Depomed. The FDA has approved metformin HCl (Glumetza), a once-daily, extended-release formulation for the treatment of Type II diabetes.Subscribe Now for Access
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