US FDA approval tracker: December

Snippets

While 2020 ended with two Covid-19 vaccines receiving emergency use authorisations from the FDA, the year also saw regulatory knockbacks and delays owing to the pandemic, a trend that will likely continue into 2021. Novartis’s cholesterol-lowering project Leqvio received a thumbs down because of a manufacturing inspection delay, an issue that also scuppered Bristol Myers Squibb’s liso-cel, whose delay led to the missing of an important December 31 CVR deadline. Elsewhere the final decision for Astrazeneca and Fibrogen’s anaemia pill Evrenzo was delayed until March pending further clinical data analyses. Lipocine, meanwhile, only received a tentative approval for its oral testosterone-replacement therapy Tlando. Lipocine is also currently embroiled in a legal wrangle with Clarus Therapeutics over intellectual property; Clarus’s own oral drug Jatenzo got its FDA nod in 2019 and the group is unlikely to want new competition.

Notable first-time US approval decisions in December
Project Company 2026e sales by indication ($m) Outcome Reason for CRL/delay?
Leqvio (inclisiran) Novartis 2,008 CRL Unresolved facility inspection-related conditions
Evrenzo (roxadustat) Astrazeneca/
Fibrogen/Astellas
1,726 Delayed
(to 20 Mar 2021)
Clinical data analysis issues
Tlando Lipocine 987 Tentative approval Not eligible for final approval until expiry of exclusivity period previously granted to Clarus Therapeutics
Gemtesa (vibegron) Urovant/ Sumitomo Dainippon Pharma 600 Approved -
Dostarlimab GSK 571 No decision yet Supposed to have been by YE
Orladeyo
(berotralstat/BCX7353)
Biocryst 385 Approved -
Margenza
(margetuximab)
Macrogenics 179 Approved -
Klisyri
(tirbanibulin)
Athenex/Almirall 132 Approved -
Ontinua ER
(extended-release arbaclofen)
Osmotica 64 CRL New efficacy study required
Brixadi Camurus/Braeburn - CRL Quality-related deficiencies
Orgovyx
(relugolix)
Myovant - Approved -
Furoscix Scpharmaceuticals - CRL CMC
Ebanga (asuvimab) Ridgeback Biotherapeutics - Approved (~1 mth early) -
Source: EvaluatePharma & company releases.

 

Advisory committee meetings in December
Project Company 2026e sales by indication ($m) Outcome Note
Entresto Novartis 4,052* Positive Proposed indication of heart failure with preserved ejection fraction, PDUFA due Q1
*SBI data not split out. Source: FDA adcom calendar & EvaluatePharma.

 

FDA issued EUAs for Covid-19 vaccines
Project Company 2026e sales by indication ($m) Setting
Comirnaty (BNT162b2) Pfizer/Biontech 649 Prevention of Covid-19 (after positive adcom also in December)
mRNA-1273 Moderna 3,122 Prevention of Covid-19 (after positive adcom also in December)
Source: EvaluatePharma & company releases.

 

Supplementary and other notable approval decisions in December
Product Company Indication (clinical trial) Outcome
Bijuva Therapeuticsmd 0.5mg/100mg dose for menopause (Replenish) No decision yet
Hetlioz Vanda Hetlioz capsules and liquid formulation used to treat Smith-Magenis Syndrome (pivotal Ph2/3 data) Approved
Ocrevus Roche Two-hour infusion time, dosed twice yearly for relapsing or primary progressive MS (Ensemble Plus) Approved
Riabni (ABP 798; Rituxan biosimilar) Amgen/Abbvie CD20-positive B-cell NHL, CLL, RA (NCT02792699, Jasmine) Approved
Krabeva/MYL-1402O
(Avastin biosimilar)
Biocon/Mylan 1L and 2L met colorectal cancer (+ fluorouracil-based chemo); 1L non-squamous NSCLC; recurrent glioblastoma; met renal cell carcinoma (+ interferon alfa); and persistent, recurrent or met cervical cancer Deferred (inspection delay)
Trikafta, Symdeko, Kalydeco  Vertex To include additional rare CFTR mutations in cystic fibrosis (based on in vitro data) Approved
Xolair Novartis/Roche Nasal polyps (Polyp 1 and 2) Approved
Gavreto Blueprint/Roche Ret-altered thyroid cancers (Arrow) Approved
Saxenda Novo Nordisk Obesity in adolescents (12-17 year olds)  (NCT02918279) Approved
Generic form of Advair Diskus Vectura/Hikma Asthma, COPD Approved
Benlysta GSK Lupus nephritis (Bliss-LN) Approved
Tagrisso Astrazeneca Adjuvant treatment of EGFR-mutated lung cancer (Adaura) Approved
Xpovio Karyopharm 2nd-line multiple myeloma (Boston) Approved (~3 mnths early)
Opdivo Bristol Myers Squibb Small-cell lung cancer (confirmatory studies Checkmate-331 and 451) Approval withdrawn (lack of efficacy in confirmatory trials)
Source: EvaluatePharma & company releases.

Share This Article