More New Drugs Approved in 2017
By: Ron Lanton, President, True North Political Solutions
The Food and Drug Administration (FDA) has already surpassed the number of new drug approvals from last year, which was a lean year with just 22 new approvals total. In 2014 and 2015, however, the agency approved 45 and 41 therapies respectively. By the numbers, it looks like 2017 will be another great year for drug approvals. Not only are approvals on the rise, many of the new approvals are the first of their kind in the United States. Below are some of the most noteworthy approvals plus a review of what may be in store for the rest of the year.
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On August 30, Kymriah was approved for the treatment of acute lymphoblastic leukemia (ALL). It is the first gene therapy in the United States to gain a green light from the FDA. Kymriah is a genetically modified autologous T-cell immunotherapy, which uses the patient’s own T-cells to attack cancer cells. Currently, the therapy is only available for patients up to 25 years of age. One of the first children treated with the therapy has remained cancer free for five years. Many in the industry are hopeful that this type of therapy will be approved for older patients soon.
Ocrevus, approved on March 28, is the first drug to treat primary progressive multiple sclerosis (PPMS). The treatment is already proving to be a game changer for those with PPMS — the data suggests that it is the first medication to show a slowdown in disability compared to a placebo.
Another game-changing drug, Ingressa, was approved on April 11 as the first and only treatment for tardive dyskinesia. Tardive dyskinesia (TD) is a movement disorder that results in involuntary muscle movements in patients on long-term antipsychotics. Previously, the only treatment for TD was to lower the dose of the antipsychotics or to halt treatment for mental illness altogether. Ingressa also does not have a black box warning for depression, which may enable this drug to become a widely used treatment for TD.
Biosimilars have been a growing trend, and several have been approved this year. Renflexis was approved on April 21, making it the second biosimilar for Janssen’s Remicade. On August 25, a second biosimilar for AbbVie’s Humira, Cyltezo, was also approved. This is the first time that two reference products have each had a second biosimilar. Most recently, on September 14, Amgen and Allergan’s Mvasi was approved as a biosimilar for Avastin. Mvasi is the first biosimilar for cancer treatment.
Because there are still two more biosimilars awaiting possible approval, 2017 could be a record year, topping off at five approvals. Coherus is hoping to gain approval for CHS-1701, referencing Amgen’s Neulasta, while Mylan is seeking approval for MYL-1401O, a biosimilar for Herceptin.
Another anticipated drug in the pipeline would be a second gene therapy, providing some competition in the oncology space for Kymirah. In August, Gilead purchased Kite Pharma, primarily to acquire Kite’s Zuma-1, which is a CAR T-cell therapy that could be approved in November. Bluebird Bio and Juno Therapeutics may also contribute to this ground-breaking space in the coming years.
Lastly, the beginning of 2017 saw the approval of the first-ever treatment for the rare disease of Duchenne muscular dystrophy, or DMD. Another drug for this disease could be approved this year. PTC Therapeutics’ Ataluren is slated for review by the FDA’s advisory committee sometime this month. If the committee votes in favor of approval, DMD patients could have a second treatment option for this rare disease.
This year is shaping up to be more than just a year with a larger number of approvals; it is becoming a year of innovation. At the end of 2017, we may look back and see the most prolific year in approvals of groundbreaking therapies.