Key approvals see big sales in first months

Among the 22 novel new drugs approved by the Food and Drug Administration in 2016, about half were considered specialty drugs, and Diplomat identified four key specialty approvals that innovate in certain categories. Two of these were in the hepatitis C space, which has driven specialty growth for several years.

(To view the full Category Review, click here.)

Gilead’s Epclusa (velpatasvir and sofosbuvir), approved in January, currently is the only treatment on the market that offers a singletablet regimen for patients with genotype 1–6 chronic hepatitis C — a U.S. patient population estimated between 2.7 million and 3.9 million. Despite being on the market for less than half the year, Gilead reported that Epclusa brought in U.S. sales of $1.6 billion for the company in 2016.

Also in the hepatitis C space was Merck’s Zepatier (elbasvir and graziprevir), which received breakthrough therapy designation for certain genotype 1 patients and genotype 4 patients. The total patient population for the drug is around 71% of the total hepatitis C patient population, and Merck reported Zepatier sales of $488 million in the United States, with $180 million in fourth-quarter U.S. sales.

The drug with the largest patient population (7.5 million) was Eli Lilly’s Taltz (ixekizumab), a new treatment for certain plaque psoriasis patients. Upon approval in March 2016, the drug joined the therapeutic class of such blockbuster drugs as Cosentyx, Enbrel, Humira and Remicade. In 2016, Taltz drew $110 million in sales.

On the other end of the patient population spectrum was AbbVie’s Venclexta (venetoclax), a treatment for certain patients with chronic lymphocytic leukemia that can treat about 20% of CLL patients — 18,960 cases were diagnosed in 2016. The drug was given accelerated approval based on overall response rate, and though AbbVie has not disclosed sales, Thomson Reuters’ “Drugs To Watch 2016” report projected that it would see $1.5 billion in sales by 2020.