It was another banner year for drug approvals by the FDA. At year’s end, the agency had stamped approvals onto about 50 new drugs, including some first-in-class treatments that are expected to reach blockbuster status. Several big sellers also won expanded indications that could help propel them to the $1 billion mark.
Here are some of the most noteworthy FDA OKs of the year:
Amarin’s Vascepa — A heart medication derived from fish oil, Vascepa was the target of notable buzz — and controversy — leading up to its most recent approval. Despite already being OK’d to treat high levels of triglycerides, Amarin won the real prize in December with an expanded indication as a preventative medication for heart attacks and strokes. The company estimates that sales for Vascepa will be reach “multiple billions of dollars” after 2020.
Eli Lilly’s Taltz — Although Taltz had already been approved to treat severe plaque arthritis, the FDA’s nod in August for ankylosing spondylitis is expected to propel sales for the drug past the $1 billion mark as soon as this year.
Regeneron and Sanofi’s Dupixent — Dupixent was already close to reaching blockbuster status with its approval for moderate-to-severe asthma. Then in June, the FDA approved it for nasal polyps as well, which is expected to lift Dupixent to sales close to $2 billion this year. Dupixent was also the first biologic approved for nasal polyps.
AbbVie’s Skyrizi — Although the market for psoriasis treatments has become increasingly crowded, AbbVie’s potential blockbuster, Skyrizi, has a unique advantage: it is administered as an injection just four times a year. The drug is also being studied for Crohn’s disease and psoriatic arthritis, and AbbVie predicts its peak sales will hit $4-5 billion.
Novartis’ Zolgensma — Now the world’s most expensive drug, Zolgensma, a gene therapy designed to treat the root cause of spinal muscular atrophy, has lived up to the hype with fast-growing sales in its first year of being approved — despite its $2 million price tag. Analysts at EvaluatePharma predict that sales for Zolgensma will pass the $1 billion mark in 2024.
Celegene and Acceleron Pharma’s Reblozyl — After winning its FDA nod in 2019, Reblozyl became the first-ever approved medication that works by regulating late-stage red blood cell maturation in patients will beta thalassemia who require regular blood transfusions. Sales for the medication are expected to reach $2 billion this year.
See the FDA’s full list of its 2019 drug approvals.
