Specialty Pharmacy Drugs: 2016 Approvals and 2017 Forecasts

A new report on the current state of specialty pharmacy, significant FDA approvals in 2016, and the drug pipeline for 2017 was recently published by Diplomat Pharmacy, Inc.

Compared with 2015, less than half of the amount of new drugs were approved by the FDA in 2016. Of the 22 novel drugs approved in 2016, 17 specialty drugs were granted expanded indications, according to Diplomat.

Seven new biologics were approved, which included a mix of immunology, rare diseases, oncology, and medications for other disease states.

Although there were fewer drug approvals in 2016, it does not signify slower growth in the specialty marketplace, and does not account for the impact of the drugs that were approved, Diplomat reported.

“The specialty pharmacy industry continues to show exceptional growth,” Paul Urick, president of Diplomat, told Yahoo Finance. “The development of new drugs, as well as expanded indications for previously approved treatments continues to make the robust specialty drug pipelines one of the major drivers of growth.”

Diplomat expects a fairly wide scope of drugs to enter the market in 2017 across specialty disease states. Additionally, they expect more novel oral oncology drugs to be approved this year compared with 2016, with several approvals forecast in breast and blood cancers.

Thirty-one specialty drugs are expected to be approved in 2017, with several drugs in particular to monitor in the coming months, according to Diplomat.

If approved in the first quarter of 2017, ocrelizumab will be the first drug specifically indicated for primary progressive forms of multiple sclerosis (MS), which affect approximately 15% of all MS patients, and will be a viable treatment option for individuals with relapsed-remitting MS.

New oral agents for acute myeloid leukemia (AML) are expected to be on the FDA review docket for 2017 and early 2018, according to Diplomat. The oral drug midostaurin was filed with the FDA for the treatment of AML in patients with FLT-3 genetic mutation and aggressive systemic mastocytosis. Enasidenib is designed to treat AML patients with IDH-2 genetic mutation, and has an expected FDA decision date of mid-2017. Gilteritinib is currently undergoing phase 3 trials in FLT-3+ AML patients.

Two drugs for atopic dermatitis are also expected to launch in 2017: crisaborole (Eucrisa), a topically administered PDE4 inhibitor received approval on December 14, 2016. Dupilumab, a subcutaneously dosed IL-4 and -13 antagonist, has a PDUFA date of March 29, 2017. According to Diplomat, it remains to be seen whether the 2 agents will mostly be distributed through specialty or retail pharmacies.

Key approvals in 2016 were as follows:

Velpatasvir and sofosbuvir (Epclusa) was approved for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1 to 6, with or without cirrhosis. It is indicated for use in combination with ribavirin for patients with decompensated cirrhosis.

Ixekizumab (Taltz) was approved for the treatment of moderate-to-severe plaque psoriasis in adults eligible for systemic therapy or phototherapy. Venetoclax (Venclexta) was approved for the treatment of chronic lymphocytic leukemia for patients with 17p deletion—–detected by an FDA-approved test––and who received at least 1 prior therapy. Elbasvir and grazoprevir (Zepatier)was approved for treating adults with chronic HCV who have genotype 1 or 4 infection.

Additionally, the following drugs received FDA approval in 2016:

• Secukinumab (Cosentyx) — psoriatic arthritis and ankylosing spondylitis
• Grazoprevir and elbasvir (Zepatier) — HCV genotypes 1 and 4
• Palbociclib (Ibrance) — breast cancer, HR+, HER2- (new combination with fulvestrant)
• Daclastasvir (Daklinza) — HCV with HIV coinfection, advanced cirrhosis, and post-liver transplant HCV reccurence
• Ledipasvir and sofosbuvir (Harvoni) — HCV, specific patients with advanced liver disease
• Everolimus (Afinitor) — gastrointestinal or lung neuroendocrine tumors
• Emtricitabine, rilpivirine, and tenofovir alafenamide (Odefsey) — HIV
• Coagulation factor IX (Idelvion) — hemophilia B
• Ibrutinib (Imbruvica) — first-line treatment for chronic lymphocytic leukemia
• Crizotinib (Xalkori) — non-small cell lung cancer, ROS1+
• Antihemophilic factor (Kovaltry) — hemophilia A
• Ixekizumab (Taltz) — psoriasis
• Reslizumab (Cinqair) — severe asthma
• Defibrotide sodium (Defitelio) — hepatic veno-occlusive disease
• Emtricitabine/tenofovir/alafenamide (Descovy) — HIV
• Influximab-dyyb (Inflectra) — multiple indications (Remicade biosimilar)
• Venetoclax (Venclexta) — CLL with 17p deletion
• Afatinib (Gilotrif) — squamous cell carcinoma of the lung
• Cabozantinib (Cabometyx) — renal cell carcinoma
• Ibrutinib (Imbruvica) — small lymphocytic leukemia
• Lenvatinib (Lenvima) — RCC
• Antihemophilic factor (Afstyla) — hemophilia A
• Obeticholic acid (Ocaliva) — primary biliary cholangitis
• Daclizumab (Zinbryta) — relapsing forms of MS
• Sofosbuvir/velpatasvir (Epclusa) — HCV all genotypes
• Adalimumab (Humira) — Uveitis
• Dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira XR) — HCV genotype 1
• Etanercept-szzs (Erlizi) — multiple indications (Enbrel biosimilar)
• Immune globulin subcutaneous (Cuvitru) — primary immunodeficiency
• Eteplirsen (Exondys 51) — Duchenne muscular dystrophy
• Adalimumab-atto (Amjevita) — multiple indications (Humira biosimilar)
• Canakinumab (Ilaris) — periodic fever syndromes
• Ustekinumab (Stelara) — Crohn’s disease
• Lumacaftor/ivacaftor (Orkambi) — cystic fibrosis in pediatric patients aged 6 to 11 years with F508del genetic mutation)
• Maraviroc (Selzentry) — HIV in pediatric patients 2 years and older
• Etanercept (Enbrel) — psoriasis in pediatric patients aged 4 to 17 years
• Tenofovir alafenamide (Vemlidy) — HBV
• Crisaborole (Eucrisa) — atopic dermatitis
• Rucaparib (Rubraca) — ovarian cancer
• Nusinersen (Spinraza) — spinal muscular atrophy