FDA Updates

Eli Lilly’s lasmiditan (Reyvow) C-V 50 mg and 100 mg for the acute treatment of migraine is now available for prescription.

Seqirus’ influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz) is the first-ever adjuvanted, cell-based vaccine to protect against pandemic influenza A (H5N1). 

Peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia, Aimmune) is the first approved treatment for patients with peanut allergy.

OptumRx’s most recent pipeline outlook for 2020 reveals key therapeutic areas in the lineup.

Officials with the FDA have approved ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc.) injection 100 mg/mL. 

Alkermes is seeking FDA approval for its investigational antipsychotic drug candidate ALKS 3831 for schizophrenia and bipolar I disorder.

If approved, dupilumab (Dupixent, Regeneron and Sanofi) would be indicated for use as an add-on maintenance treatment for children ages 6 to 11 years with moderate-to-severe atopic dermatitis.

Fidaxomicin (Dificid, Merck) is indicated in adults and pediatric patients aged 6 months and older for the treatment of Clostridioides difficile-associated diarrhea.

Pfizer announced the introduction of 3 new oncology biosimilars to the US market at a substantially discounted price.

FDA approval decision expected in the second quarter of 2020.

Solriamfetol (Sunosi, Jazz Pharmaceuticals) to treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea was approved on March 20, 2019.

The FDA has approved semaglutide (Ozempic, Novo Nordisk) for the reduction of major adverse cardiovascular (CV) events in patients with type 2 diabetes and established CV disease.

Novavax’s recombinant quadrivalent flu vaccine candidate (NanoFlu) is being evaluated in an ongoing phase 3 clinical study for use in older adults.

Here are the top drugs expected to be approved this year.

Viaskin Peanut (DBV Technologies) achieved durable, long-term clinical benefit in peanut-allergic children.

AstraZeneca’s supplemental New Drug Application for dapagliflozin (Farxiga) has been granted Priority Review by the FDA.

Insulin aspart injection (Fiasp, Novo Nordisk) has been approved for use as a new mealtime insulin option for children with diabetes.

The New Drug Application is seeking approval for ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV in adults.

Olaparib (Lynparza, Merck and AstraZeneca) is approved for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic cancer.

The approvals were granted to generic apixaban applications from Micro Labs Limited and Mylan Pharmaceuticals Inc.

Our most-read FDA approval articles from 2019. 

Ubrogepant (Ubrelvy) is the first oral calcitonin gene-related peptide receptor antagonist approved by the FDA for the acute treatment of migraine.

Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo and AstraZeneca) is a new treatment option for patients with HER2-positive breast cancer who have progressed after 2 or more prior regimens.

20% subcutaneous immunoglobulin therapy.

Officials with the FDA have approved a new indication and label expansion for icosapent ethyl (Vascepa, Amarin).

Biosimilar to Remicade

Allergan’s positive phase 3 trial results indicate a potential use for the CGRP receptor agonist.

Recent approval under new international Project Orbis.