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FDA Approves Novo Nordisk’s Obesity Drug Wegovy
In addition to the obesity drug, FDA approves the first treatment for patients with plasminogen deficiency type 1 and Chimerix Inc’s Tembexa to treat smallpox.
FDA recently approved Novo Nordisk’s Wegovy obesity drug for chronic weight management in overweight adults with at least one weigh-related condition, including high blood pressure, type 2 diabetes, or high cholesterol.
Wegovy must be used in addition to a reduced calorie diet and increased physical activity, according to the approval.
The drug is indicated for patients with a body mass index (BMI) of 27 kilograms/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kilograms/m2 or greater.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in the announcement.
“FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight,” Sharretts continued.
Wegovy mimics a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication must be increased over 16 to 20 weeks to 2.4 milligrams once weekly to reduce gastrointestinal side effects.
In four 68-week trials, over 2,600 patients received Wegovy and more than 1,500 patients received a placebo. Three of the trials were randomized, double-blind, and placebo-controlled while one trial was a double-blind, placebo-controlled, randomized withdrawal trial.
Individuals who received Wegovy lost an average of 12.4 percent of their initial body weight compared to individuals who received a placebo. An additional trial enrolled adults with type 2 diabetes. Individuals who received Wegovy lost 6.2 percent of their initial body weight compared to those who received a placebo.
Common side effects of the injection include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dizziness, hypoglycemia, and gastroenteritis.
FDA noted that Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other products intended for weight loss. This includes prescription drugs, over-the-counter drugs, and herbal products.
Additionally, the prescribing information for Wegovy contains a warning to inform healthcare professionals and patients about the risk of thyroid C-cell tumors. Therefore, the injection should not be used in patients with a family history of medullary thyroid carcimoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
FDA Approves First Treatment for Patients with Plasminogen Deficiency
FDA recently approved ProMetic Biotherapeutics’ Ryplazim, the first treatment for patients with plasminogen deficiency type 1, or hypoplasminogenemia.
Hypoplasminogenemia is a rare disorder that can impair normal tissue and organ function and may lead to blindness. Individuals affected by this disease lack a protein called plasminogen, which helps the body’s ability to break down fibrin clots.
Ryplazim contains plasminogen, which is purified from human plasma. The drug helps to boost the plasma level of plasminogen, enabling temporary correction of the plasminogen deficiency and reduction or resolution of the lesions.
FDA determined the effectiveness and safety of the drug based on one single-arm, open-label clinical trial that enrolled 15 adult and pediatric patients with plasminogen deficiency type 1. In the study, all patients received Ryplazim every two to four days for 48 weeks.
The effectiveness of Ryplazim was demonstrated by at least 50 percent improvement in lesions in all 11 patients who had lesions at baseline, as well as absence of recurrent or new lesions in any of the 15 patients through the 48 weeks of treatment.
“Until now, there were no FDA-approved treatment options for patients with plasminogen deficiency type 1,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in the announcement.
“Today’s approval helps address an unmet medical need for individuals affected by this rare genetic disease,” Marks continued.
FDA Approves Smallpox Drug to Bolster Public Health
FDA recently approved Chimerix Inc’s Tembexa to treat smallpox.
Although smallpox has not existed since 1980, there have been concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon.
The variola virus spreads by direct contact among people. Typically, symptoms begin 10 to 14 days after infection and include fever, exhaustion, headache, and backache. Complications of the disease include encephalitis, corneal ulcerations, and blindness.
The effectiveness of Tembexa was studied in animals infected with the viruses that are closely related to the variola virus. Overall effectiveness was determined by measuring animal survival at the end of the studied.
Animals treated with the drug survived compared to the animals treated with the placebo. The most common side effects of Tembexa were diarrhea, nausea, vomiting, and abdominal pain.
Based on the data, FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal studies to serve as the basis of an approval when it is not feasible to conduct an efficacy trial in humans.
Tembexa was developed in conjunction with HHS’ Biomedical Advanced Research and Development authority (BARDA). Overall, the drug received priority review, fast track, and orphan drug designations.
