Following the trends of recent years, 2017 is expected to see the U.S. Food & Drug Administration approve several specialty drugs, meaning new treatment options for patients with rare and complex diseases.
In 2016, the specialty drugs accounted for 71% of the 24 drugs to gain FDA approval. Specialty drugs to treat rare conditions, as well as complex diseases such as cancer, have accounted for the majority of FDA approvals for the past six years as drug manufacturers devote more time and money to developing specialized treatments. And 2017 has the potential to see several more specialty drugs gain approval.
It’s going to be an active year for FDA approvals, with specialty drugs dominating once again. There is a lot going on in this dynamic market, and there’s a lot of innovation taking place.
Several disease states – including multiple sclerosis, cancer and atopic dermatitis – have already seen new treatment options gain FDA approval this year.
New specialty drugs to treat inflammatory conditions, such as rheumatoid arthritis (RA) and psoriasis, could potentially gain FDA approval this year, resulting in more treatment options for patients and more competition among drug manufacturers.
- Guselkumab is expected to gain approval in July. This is a new treatment for psoriasis patients and will compete with other biologics already on the market.
- Sirukumab is a subcutaneous therapy similar to Actemra for the treatment of RA. It is expected to gain FDA approval in September.
- Ocrelizumab gained FDA approval March 28 for the treatment of relapsing multiple sclerosis (MS) and primary progressive MS. It is the first drug approved for the treatment of primary progressive MS. It is administered through IV infusion every six months with an annual cost of $65,000 per patient.
- Dupilumab was approved March 28 for moderate to severe atopic dermatitis in patients who don’t respond to topical prescription therapy. As many as 400,000 patients in the US will be candidates for treatment with dupilumab, a breakthrough therapy filling an unmet need.
- Valbenazine was approved April 11 for the treatment of tardive dyskinesia (TD). TD, a sometimes permanent side effect of antipsychotic medications, causes patients to have stiff, jerky movements of their face and body that they can't control. Valbenazine is a breakthrough therapy and is the first drug approved for TD, which affects as many as 500,000 Americans.
- Deutetrabenazine was approved by the FDA on April 3 for the treatment of chorea associated with Huntingdon’s disease. Roughly 9,000 patients are candidates for treatment. The drug is expected to gain expanded approval Aug. 30 as another treatment for TD.
2017 will see significant development for new cancer therapies, with many of them being oral, targeted therapies.
- Niraparib is an oral medication was approved March 27. It is for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy.
- Avelumab gained FDA approval in March for metastatic Merkel cell carcinoma (MCC) with disease progression following at least one chemotherapy treatment. The drug is expected to gain expanded approval in August for metastatic urothelial carcinoma.
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- Cerliponase alfa was approved on April 27. It is an enzyme replacement therapy for late infantile neuronal ceroid lipofuscinosis type 2. This is the first treatment option for these patients.