FDA Updates

On December 23, 2019, the FDA approved ubrogepant for the acute treatment of migraine with and without aura in adult patients.

Empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) is being investigated to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.

Nintedanib (Ofev, Boehringer Ingelheim Pharmaceuticals) has been approved for the treatment of chronic fibrosing interstitial lung disease with a progressive phenotype.

Advil Dual Action, an ibuprofen and acetaminophen fixed-dose combination, has been approved as an OTC product for pain relief.

Pyrimethamine (Daraprim) tablets are used to treat toxoplasmosis.

Rimegepant (Nurtec ODT, Biohaven),a fast-acting orally disintegrating tablet, delivers quick and sustained efficacy for patients with migraine.

Bempedoic acid (Nexletol, Esperion) is a new lipid-lowering therapy option for patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease.

Eptinezumab-jjmr (Vyepti, Lundbeck) decreased mean monthly migraine days in adult patients in 2 phase 3 clinical trials.

Solid recommendations can require detective work. 

Genentech announced new 1-year data from the SUNFISH trial evaluating risdiplam in spinal muscular atrophy.

A supplemental application for cannabidiol oral solution (Epidiolex, GW Pharmaceuticals and Greenwich Biosciences) has been submitted for the treatment of seizures associated with tuberous sclerosis complex.

Baricitinib (Olumiant, Eli Lilly and Incyte) demonstrated positive results in the BREEZE-AD5 study of patients with atopic dermatitis.

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.

Lefamulin was approved by the FDA in August 2019 for the treatment of CABP.

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.