Following a clinical trial, the U.S. Food and Drug Administration is now allowing AstraZeneca to sell a new drug, Entresto, which can be used to help people with heart failure or multiple sclerosis.
The agency announced Tuesday that the drug will be available to patients who cannot tolerate their current drug, as well as those who are allergic or just aren’t getting the benefits of their drugs. The drug is currently only approved for treating heart failure.
Prior to the FDA approving the drug, Entresto was already being touted as an innovative drug by AstraZeneca, which started selling it in the U.S. in April 2015. The brand name is alirocumab, and the idea behind the drug is that it’s an ultra-long-acting formulation of aspirin, to treat heart disease.
The FDA approved the product by considering data from clinical trials, which showed that patients who take the drug were able to keep blood pressure and blood oxygen levels under control for an additional five to 10 hours. More importantly, long-acting drugs are known to have fewer side effects, like gastrointestinal side effects. In testing, 40 percent of patients experienced diarrhea.
“Evidence suggests long-acting insulins may offer significant advantages in terms of patient convenience, fewer systemic side effects, and lowered treatment costs over single-entity insulin alternatives for type 2 diabetes,” said FDA Commissioner Scott Gottlieb, in a statement.
In March, the FDA approved the drug for people with ulcerative colitis, a type of inflammatory bowel disease that causes ulcers in the colon.
The FDA has long encouraged doctors to prescribe long-acting drug therapies to help control weight, blood pressure and cholesterol. Patients who can’t tolerate a short-acting drug include those with diabetes, chronic obstructive pulmonary disease, heart failure, rheumatoid arthritis, and cancer.
“The risks of long-acting agent treatment include the possibility of drug-induced ketoacidosis and auto-immune reactions,” the FDA said.
According to a partnership between AstraZeneca and Apple, the goal of Entresto is to help replace or supplement other conventional therapies. According to the partnership’s website, the drug will help patients stay on their antidepressant regimen, or help those with Parkinson’s disease prevent physical tremors or dementia.
In June, the FDA approved the drug for people with type 1 diabetes who do not respond to metformin or insulin, and also added a “black box” warning for drug-induced bleeding on the product.
AstraZeneca chose to focus on heart failure and Parkinson’s disease earlier on, perhaps because long-acting drugs seem to have less risk of side effects or problems with patients with diabetes.
“The difference in these patients seems to be a higher chance that they will avoid insulin and diet change and the opposite is true for people with type 1 diabetes or those with Parkinson’s disease,” said Jeffrey Lorch, a cardiologist and associate professor of medicine at the University of North Carolina, Chapel Hill.
AstraZeneca’s other drug in the partnership, Stelara, a monoclonal antibody, is also approved for people with Parkinson’s disease.
Last month, the FDA approved the addition of Ambien’s Bedrock formulation to the drug’s list of medications approved to prevent urinary tract infections.