On Friday, the FDA announced that it has approved the cholesterol lowering drug alirocumab, a drug marketed under the brand name of Praluent. According to experts, alirocumab is the first member of a new class of drug known as PCDK9 inhibitors. This injectable drug manufactured by Regeneron and Sanofi works by increasing liver’s efficiency in eliminating bad cholesterol or LDL.
FDA has approved Praluent for patients suffering from HeFh or heterozygous familial hypercholesterolemia. For those who don’t know: HeFh is an inherited health disorder that leads to increase in the patient’s LDL cholesterol levels. The drug has also been approved for patients who have suffered a stroke or heart attack.
Dr. Donald Smith of Mount Sinai Hospital in New York said that the newly approved drug focuses on individuals who have truly suffered from clinical diseases or have LDL levels which have become so high that bringing them close to what’s normal has become almost impossible. According to Dr. Smith, these people are at maximum risk of encountering severe cholesterol-related health issues. Dr. Sinai is the associate professor of cardiology and medicine at the hospital.
Approval of this drug makes another treatment option available for patients who are not experiencing any improvement even after being treated with existing medications. The drug will also be useful for patients who develop side effects after taking the currently available medications.
At present, the class of drugs doctors prescribe to patients with high levels of LDL is called statin. The market currently has seven different types of statins.
Dr. Smith believes that further research will allow alirocumab to be approved more widely for people who are at high risk of having cholesterol-related health disorders, but are yet to suffer a stroke or heart attack.
Regeneron has already announced that this new drug will be available by early next week. Medicine stores will have the drug in two different doses. The drug will be marketed in form of a pre-filled pen that patients will have to administer one in every two weeks.
The drug’s wholesale price for each month will be around $1,200. This makes the drug much costlier than statins. Yearly expenditure for the brand-name versions of statins ranges from $500 to $700; generics, on the other hand, require patients to spend just $48 per year.