Several blockbusters among the FDA’s 50 new drug approvals for 2019

Jan. 7, 2020

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.