2018 is poised to be a promising year in terms of new medications the U.S. Food and Drug Administration (FDA) will be considering for approval. This pipeline of potential new specialty pharmacy medications includes a new psoriasis medication, a few new multiple sclerosis medications, and several medications for oncology.
In terms of new treatment options, 2017 certainly ranked as a big year; especially in comparison to the smaller-than-average number of approvals that happened in the previous year (2016). The number of new medications (and medications with new and expanded indications) approved by the FDA in 2017 included several game-changing treatments. In short, it was a very significant year.
Let’s take a look at medications approved last year in a handful of important treatment areas:
Early in the year, Harvoni (ledipasvir/sofosbuvir) was given an expanded treatment indication for additional genotypes of hepatitis C infections. Shortly after, Sovaldi (sofosbuvir) received expanded indications as well. Epclusa (sofosbuvir/velpatasvir) was also approved for expanded treatment indications.
Two new hepatitis C medications joined the treatment options for patients. Last summer both Mavyret (glecaprevir and pibrentasvir) from AbbVie and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) from Gilead entered the market.
Cancer treatment saw the lion’s share of approvals. The vast number here included a few notables such as Calquence (acalabrutinib) for mantel cell lymphoma, Alecensa (alectinib) as a first-line treatment option for advanced non-small cell lung cancer, Opdivo (nivolumab) for advanced liver cancer and for metastatic colorectal cancer, Keytruda (pembrolizumab) for stomach cancer, and an approval of a cooling cap device to reduce hair loss during chemotherapy.
The big news for MS was the approval of Ocrevus (ocrelizumab) from Genentech, specifically for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis.
Two new medications were approved for plaque psoriasis: Siliq (brodalumab) from Valeant Pharmaceuticals and Tremfya (guselkumab) from Janssen Biotech. In addition, Dupixent (dupilumab) from Regeneron Pharmaceuticals was approved for the treatment of atopic dermatitis. Additionally, Humira (adalimumab) got a nod of approval for also working for fingernail psoriasis and Orencia (abatacept) received an expanded FDA approval for psoriatic arthritis.
Kevzara (sarilumab) from Sanofi and was approved for the treatment of active rheumatoid arthritis. Meanwhile, Renflexis (infliximab-abda) gained approval as a biosimilar for Remicade (infliximab).
Keep in mind that it’s a multi-year process to bring a medication from early research all the way through FDA approval. So medications can stay in the pipeline for quite a while. 2018 is expected to be an exciting year of FDA approvals.
Toich L. 2018 Pipeline Highlights. Sp Pharm Times Oct 5, 2017.
2017 FDA approved drugs. CenterWatch https://www.centerwatch.com/drug-information/fda-approved-drugs/