Drug Approvals Reached Record-High In 2017
Before patients can take prescriptions to a pharmacy and get their medications, FDA has to approve drugs first. The process of approving medications is rigorous and prior to making a decision, manufacturers have to send evidence to FDA that explain how their drugs work, symptoms they treat*, proof of their efficacy, among other things.
The Food and Drug Administration of the US doesn’t have the tendency to approve a lot of drugs on a yearly basis, but in 2017 they gave a green light to a record number of medications.
How Many Drugs Did FDA Approve?
According to the annual report Novel Drug Approvals for 2017, FDA approved 46 drugs and therapeutic biological products. The report states that FDA supports the pharmaceutical industry at every step at the process, but it emphasizes innovation. The idea is that brands develop medications that will not only be effective, but safe at the same time.
After 46 new drugs got the green light, FDA broke its 21-year-old record. It’s important to mention that although approvals were high in some previous years this fact only applies to novel drugs only. For comparison, FDA approved 22 drugs in 2016.
If you think that the US approved “too many” drugs, the European Union was no different either. The EU approved 92 new drugs including generics, up from 81 in 2016. Reports show that China plans to expand its pharmaceutical market by approving more drugs too.
Although 46 may seem like a huge number today when most people use drugs even though they may not need them, it’s good news for patients who suffer from different health conditions. A vast majority of approved medications in 2017 were formulated to address rare diseases and subtypes of cancer.
Rare diseases can be difficult to treat* due to the lack of information and studies that would elucidate underlying mechanisms.
Interestingly, the 46 approved drugs tally doesn’t include gene therapies from Gilead Sciences, Novartis, and Spark Therapeutics despite the fact they got the green light in 2017. The reason is simple; they are registered under a different category.
Gene therapies are overseen by the Center for Biologics Evaluation and Research (CBER) and as a result, those major discoveries are absent from the list of approved medications. Below, you can see some, out of 46, approved medications.
Emflaza is a medication created specifically to treat* patients age five years and older with Duchenne muscular dystrophy, a genetic disorder characterized by progressive muscle degeneration and weakness.
The drug is, actually, a corticosteroid, but its approval is controversial. Makers of the product, Marathon Pharmaceuticals, decided to sell their product for $89,000 which is outrageous if we bear in mind the price for the same product overseas is $0.60 per dose.
Radicava was created to treat* patients with amyotrophic lateral sclerosis (ALS). Approval of this drug bypassed common practices that FDA usually employs before they give green light to someone. The drug was approved without additional clinical trials.
Before you start thinking it’s some shady business, there’s a simple explanation – most ALS patients die within five years of diagnosis due to rapid progression of the disease so it’s important to ensure they get a treatment as soon as possible. Plus, Radicava is the second ALS medication approved in 20 years.
Nerlynx is a medication for the treatment of HER-2 positive breast cancer. Basically, the drug aims to lower the risk of breast cancer recurrence. Like many other approvals, this drug also raised some eyebrows mainly because it’s believed that breast cancer doesn’t have high recurrence rates, but recent findings showed it can happen more frequently than we think.
Read More: One-Third Of FDA-Approved Drugs Have Safety Issues
In 2017, FDA approved 46 novel drugs, a record-high for this agency. Most drugs were formulated for cancer subtypes and rare diseases. Increased rates of drug approvals were also recorded in EU and China.
 https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm http://fortune.com/2018/01/02/new-drug-approvals/