US FDA approval tracker February 2021

Backed by a positive panel meeting Johnson & Johnson’s JNJ-78436735 became the third Covid-19 vaccine granted US emergency use authorisation (EUA), but it is the first that requires only one dose. The company plans to deliver 100 million doses to the US during the first half of the year. An EUA was also granted to Lilly’s bamlanivimab plus etesevimab after the antibody combo significantly cut Covid-19-related hospitalisations and deaths in studies. February saw Bristol Myers Squibb’s Breyanzi become the third anti-CD19 Car-T therapy approved, and the project’s efficacy looks on a par with Gilead’s Yescarta, with less toxicity. However, Breyanzi is even more expensive to manufacture than existing Car-T products. Novartis’s Entresto gained approval in a broad heart failure population, but the group will need to make the most of this before generic competition hits. And Athenex had a knockback for Oraxol, a combination of oral paclitaxel and encequidar, in metastatic breast cancer. The FDA cited toxicity concerns and requested another clinical study. The Pdufa was scheduled for the last day of February and the news, released today, knocked half a billion dollars off the company's market cap.

Notable first-time US approval decisions in February
Project Company 2026e sales by indication ($m) Outcome
Breyanzi (liso-cel) Bristol Myers Squibb 1,096 Approved
Oraxol (oral paclitaxel + encequidar) Athenex 781 CRL
Cosela (trilaciclib) G1 Therapeutics 583 Approved
Tepmetko (tepotinib) Merck KGaA 505 Approved
Pepaxto (melphalan flufenamide/melflufen) Oncopeptides 490 Approved
Ukoniq (umbralisib) TG Therapeutics 296 Approved*
Defencath/Neutrolin Cormedix 230 CRL
Amondys 45 (casimersen) Sarepta 202 Approved
Posimir Durect 195 Approved
StrataGraft Mallinckrodt 59 Deferred (manufacturing inspection)
Nulibry (fosdenopterin) Bridgebio 29 Approved
Evkeeza (evinacumab) Sanofi/Regeneron - Approved
*Gained approval in marginal zone lymphoma and follicular lymphoma. Sources: EvaluatePharma & company releases.
Advisory committee meetings in February
Project Company 2026e sales by indication ($m) Outcome
Keytruda Merck & Co 3,943* Negative, 10-0 (neoadjuvant/adjuvant use in triple-negative breast cancer)
*SBI includes the approved use in triple-negative breast cancer in combination with chemotherapy. Sources: EvaluatePharma & company releases. 
FDA issued EUAs to treat Covid-19
Project Company 2026e sales by indication ($m) Setting
Bamlanivimab + etesevimab Lilly 303 Treatment of mild to moderate Covid-19 in adults and paediatric patients aged 12 and over
Johnson & Johnson -* Prevention of Covid-19 (after positive adcom also in February)
*Consensus not yet available. Sources: & EvaluatePharma
Supplementary and other notable approval decisions in February
Product Company Indication (clinical trial) Outcome
Gocovri Adamas Off episodes in Parkinson's disease patients receiving levodopa-based therapy Approved
Plegridy (intramuscular) Biogen Relapsing-remitting MS Approved
Libtayo Sanofi/Regeneron NSCLC with ≥50% PD-L1 expression (Empower-Lung-1) Approved
Vazalore Plx Pharma Liquid-filled aspirin capsule (325mg and 81mg doses) No decision yet
Entresto Novartis Heart failure with preserved ejection fraction (Paragon HF Approved
Rapivab Biocryst Acute uncomplicated influenza to include patients six months and older Approved
Libtayo Sanofi/Regeneron Full approval in locally advanced basal cell carcinoma and accelerated approval in metastatic BCC (NCT03132636) Approved
Panzyga Pfizer Chronic inflammatory demyelinating polyneuropathy (NCT02638207) Approved
Humira Abbvie Paediatric patients with moderate to severe ulcerative colitis (Envision I) Approved
Sources: EvaluatePharma & company releases.

Share This Article