
US FDA approval tracker: December 2020
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 ($m) | Outcome | Reason for CRL/delay? |
Leqvio (inclisiran) | Novartis | 2,008 | CRL | Unresolved facility inspection-related conditions |
Evrenzo (roxadustat) | Astrazeneca/ Fibrogen/Astellas |
1,726 | Delayed (to 20 Mar 2021) |
Clinical data analysis issues |
Tlando | Lipocine | 987 | Tentative approval | Not eligible for final approval until expiry of exclusivity period previously granted to Clarus Therapeutics |
Gemtesa (vibegron) | Urovant/ Sumitomo Dainippon Pharma | 600 | Approved | - |
Dostarlimab | GSK | 571 | No decision yet | Supposed to have been by YE |
Orladeyo (berotralstat/BCX7353) |
Biocryst | 385 | Approved | - |
Margenza (margetuximab) |
Macrogenics | 179 | Approved | - |
Klisyri (tirbanibulin) |
Athenex/Almirall | 132 | Approved | - |
Ontinua ER (extended-release arbaclofen) |
Osmotica | 64 | CRL | New efficacy study required |
Brixadi | Camurus/Braeburn | - | CRL | Quality-related deficiencies |
Orgovyx (relugolix) |
Myovant | - | Approved | - |
Furoscix | Scpharmaceuticals | - | CRL | CMC |
Ebanga (ansuvimab) | Ridgeback Biotherapeutics | - | Approved (~1 mth early) | - |
Source: EvaluatePharma & company releases. |
Advisory committee meetings in December | ||||
---|---|---|---|---|
Project | Company | 2026e sales by indication ($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. |