FDA Updates

Officials with the FDA have granted priority review for mepolizumab (Nucala, GlaxoSmithKline) in the treatment of patients with hypereosinophilic syndrome.

Dupilumab (Dupixent, Sanofi and Regeneron) is the first biologic medicine approved for treatment of moderate-to-severe atopic dermatitis.

Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) is indicated for treating adults with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2–based regimens in the setting of metastasis.

Officials with the FDA granted Emergency Use Authorization (EUA) to the first diagnostic test that will allow at-home collection of saliva samples for coronavirus disease 2019 (COVID-19) testing.

Officials with the FDA have approved celecoxib oral solution 25 mg/mL (Elyxyb, Dr. Reddy’s Laboratories) for the acute treatment of migraine with or without aura in adults.

Officials with the FDA have approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction, with and without type 2 diabetes.

Rituximab-abbs (Truxima) is the only biosimilar to the reference product rituximab (Rituxan). 

Officials with the FDA have granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy, Immunomedics Inc.) for previously-treated adult patients with metastatic triple-negative breast cancer.

Officials with the FDA today approved tucatinib (Tukysa, Seattle Genetics) in combination with chemotherapy trastuzumab and capecitabine for the treatment of adults with advanced forms of HER2-positive breast cancer.

Merck has announced the US launch of trastuzumab-dttb (Ontruzant), a biosimilar to trastuzumab (Herceptin), in both 150-mg single-dose vials and 420-mg multiple-dose vials.

Officials with the FDA have granted approval to ixekizumab (Taltz, Eli Lilly) injection, 80 mg/mL for the treatment of pediatric patients with moderate-to-severe plaque psoriasis.

Officials with the FDA have approved luspatercept-aamt (Reblozyl, Bristol Myers Squibb and Acceleron Pharma) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes.

Coagulation factor VIIa (recombinant)-jncw (Sevenfact, LBF) contains an active ingredient from a genetically engineered animal.

Bempedoic acid (Nexletol, Esperion), an oral, once-daily, non-statin low-density lipoprotein-cholesterol lowering medicine, is now available in US pharmacies.

As coronavirus cases surge nationwide, retail pharmacies are facing incredibly difficult circumstances.

Officials with the FDA have approved durvalumab (Imfinzi) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with standard-of-care (SoC) chemotherapies, in adult patients.

Johnson & Johnson expects to initiate human clinical studies for its lead COVID-19 vaccine candidate by September 2020.

Officials with the FDA have granted approval to ozanimod (Zeposia, Bristol Myers Squibb) for the treatment of relapsing multiple sclerosis.

Crisaborole ointment, 2% (Eucrisa, Pfizer) has been approved for use in pediatric patients with atopic dermatitis as young as 3 months of age.

Officials with the FDA have approved a 420-mg multi-dose of trastuzumab-bttb (Ontruzant, Samsung Bioepis), a biosimilar referencing trastuzumab (Herceptin).

The FDA issued emergency use authorization of a rapid, point-of-care COVID-19 diagnostic test, developed by Cepheid, that has a detection time of approximately 45 minutes.

Analysts have forecasted the market for NASH drugs could reach $20 billion by 2025.

Dr. Reddy’s Laboratories has launched its ziprasidone mesylate 20 mg/mL for injection, the first generic version of Geodon (Pfizer) for injection. 

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.