The blockbuster drugs of 2016

After a record year for FDA drug approvals in 2015 with 45 NMEs gaining the regulatory go-ahead, the most since the all-time high of 53 set in 1996, 2016 has been a relative disappointment with only 16 NMEs approved at the time of writing. [Dec 13].

However, with nine biologicals approved in 2016 (plus one GL P1 analog), compared to 12 in 2015, the year has not been a disappointment among biologics developers, and with many breathtaking price tags it is not expected to be a disappointment for the market either. Perhaps more interestingly, 50% of the six small molecules approved in 2016 were first in class, and as such all but one are expected to be $1 billion+ blockbusters with sales forecast to outperform the biologics.
Also notable was the speed at which many of the new therapeutics negotiated the regulatory process, with 66% reaching the market through one or more forms of expedited approval. The majority were also approved in the first cycle, with no FDA requests for data clarification or additional studies.

Here we take a look at the year’s most lucrative newly approved drugs.

Epclusa – the first pan-genotypic regimen in HCV

The era of interferon-free regimens in hepatitis C (HCV) arrived in December 2013 with the FDA’s approval of Gilead’s Sovaldi for the treatment of genotype (GT) 2 and 3 patients, and the approval of Gilead’s Epclusa (sofosbuvir + velpatasvir) in June 2016 as the first all-oral pan-genotypic single tablet regimen in HCV marks a further breakthrough in the HCV setting.

Epclusa’s recommended dosing regimen is 12 weeks, regardless of genotype and/or cirrhosis, and in trials the drug achieved SVR12 of 99% in GT 1, 2, 4, 5 or 6 patients, 95% in GT3 patients, and 94% in patients with HC V1 to 6 and decompensated cirrhosis. The product is likely to be driven particularly by sales in the GT3 setting where it is expected to become standard of care based on higher SVR rates than existing options Sovaldi and Daklinza. Although GT3 patients only comprise <10 % of the total market, as the only pan-genotypic single tablet regimen Epclusa is likely to be favored outside the US where access to genotype testing may be more limited. In the US , it may not be as much of a competitive threat to current market leader Harvoni outside of GT3, which is standard of care in GT1 patients given better SVR rates and the option of 8-week dosing in patients with low viral load. However, by 2022 Cortellis for Competitive Intelligence forecasts Epclusa to become market leader, with global sales of $8.363 billion in 2022 compared with $3.536 billion for Harvoni. 

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