Year in Review: 10 Specialty Drug Approvals to Know from 2018
While there were many notable approvals, weâ€™ve rounded up a list of 10 newly-approved therapies to know from 2018.
This past year, several new drug approvals permeated the specialty pharmacy space, with an increasing number of products in the pipeline covering a range of specialty therapeutic areas.
While there were many notable approvals, we’ve rounded up a list of 10 newly-approved therapies to know from 2018.
10. Erenumab-aooe (Aimovig, Amgen)
Erenumab-aooe was approved for the preventive treatment of migraine in adults, making it the first approved preventive migraine treatment of its kind. Given by once-monthly self injections, erenumab-aooe is part of a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
9. Lanadelumab (Takhzyro, Shire)
The FDA approved lanadelumab, the first monoclonal antibody for the treatment of patients 12 years and older with types 1 and 2 hereditary angioedema (HAE), a rare hereditary disease. This new approval provides an additional treatment option for patients, which is significant because a Prime Therapeutics study found specialty drug costs were responsible for more than 97% of the total cost of care for HAE.
8. Baricitinib (Olumiant, Eli Lilly)
Baricitinib, a 2-mg dose, once-daily oral drug, received approval for adults with moderately-to-severe active rheumatoid arthritis who had an inadequate response to 1 or more tumor necrosis factor inhibitor therapies. The treatment is indicated for use as a monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs.
7. Epidiolex (GW Pharmaceuticals)
Epidiolex is a novel cannabidiol treatment indicated to treat seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, 2 rare and severe forms of epilepsy, in patients 2 years and older. It is the first FDA-approved medication that contains a purified drug substance derived from marijuana.
6. Tildrakizumab-asmn (Ilumya, Sun Pharmaceuticals)
Tildrakizumab-asmn, a novel biologic, received approval from the FDA for the treatment of moderate-to-severe plaque psoriasis among patients who are candidates for systemic therapy or photo therapy. It is indicated at a dose of 100 mg administered as a subcutaneous injection every 12 weeks, following initial doses at weeks 0 and 4.
5. Tofacitinib (Xeljanz, Pfizer)
Tofacitinib was the first Janus kinase inhibitor approved for the treatment of adult patients with moderately to severely active ulcerative colitis. Patients may take tofacitinib 10 mg twice-daily (BID) for at least 8 weeks, followed by tofacitinib 5 mg BID or 10 mg BID. With this approval, adults living with the disease now have an oral treatment option.
4. Rituximab-abbs (Truxima, Celltrion and Teva)
Rituximab-abbs, a biosimilar to Rituxan (Genentech), was the first biosimilar approved for the treatment of adults with non-Hodgkin’s lymphoma. Rituximab-abbs is 1 of 7 biosimilars approved by the FDA in 2018.
3. Emicizumab-kxwh (Hemlibra, Genentech)
Although initially approved in 2017 for adults and children with hemophilia A with factor VIII inhibitors, emicizumab-kxwh received approval in 2018 for hemophilia A without factor VIII inhibitors. This approval makes it the only treatment for both patient populations, while also providing an additional option other than intravenous infusions.
2. Pegfilgrastim-jmdb (Fulphila, Mylan GmbH)
The FDA approved pegfilgrastim-jmdb as the first biosimilar to pegfilgrastim (Neulasta). The drug is used to decrease the chance of infection, with fever, associated with an abnormally low number of infection-fighting white blood cells in patients with non-bone marrow cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
1. Fingolimod (Gilenya, Novartis)
Fingolimod received approval for the treatment of relapsing multiple sclerosis (MS) in pediatric patients aged 10 years and older, making it the first FDA-approved drug to treat MS in this population. The drug was initially approved in 2010 to treat adults with relapsing MS.