US FDA approval tracker: December

After a tough 2021, Novartis finally caught a break with the approval of Leqvio, its long-awaited cholesterol-lowering therapy. With a list price of $6,500 per year, the drug is being pitched at around the same level as the incumbent PCSK9 MAbs; early sales could indicate whether the long-acting therapy can become Novartis’s biggest ever drug, as predicted by chief executive officer Vas Narasimhan. Meanwhile, both Leo Pharma and Astrazeneca/Amgen look set to have a tough time going up against Dupixent in different indications, with Adbry and Tezspire, respectively. Efficacy data with Adbry in atopic dermatitis did not impress, while Tezspire is approved for severe asthma, versus Dupixent’s moderate-to-severe label. Leerink analysts reckon that Tezspire will be initially reserved for low-eosinophil patients who cannot receive Dupixent or other asthma biologics, putting pre-approval sellside predictions in doubt. Merck & Co could also struggle to compete with its Covid-19 antiviral molnupiravir, which got an EUA the day after Pfizer’s Paxlovid; unlike molnu, the latter sailed through without an adcom. Molnu is destined to be a last-ditch option due to lacklustre efficacy plus concerns about potential foetal toxicity and the possibility that it could accelerate viral evolution.

Notable first-time US approval decisions in December
Project Company Indication(s) 2026 SBI ($m) Outcome
Tezspire (tezepelumab) Astrazeneca/
Amgen
Severe asthma (eosinophilic & non-eosinophilic) 2,040 Approved early (was guided to Q1)
Leqvio
(inclisiran)
Novartis/
Alnylam
Adults with HeFH or ASCVD on maximally tolerated statins who need additional LDL-C lowering 2,026* Approved early (had been due Jan 1)
Vyvgart
(efgartigimod)
Argenx Myasthenia gravis 1,752 Approved
AXS-05 Axsome Major depressive disorder 893 No decision yet  
Tarpeyo
(nefecon)
Calliditas IgA nephropathy 630** Approved (accelerated)
Recorlev Xeris Biopharma (via Strongbridge) Cushing's syndrome 255 Approved early (had been due Jan 1)
Eohilia
(TAK-721)
Takeda Eosinophilic esophagitis 188 CRL (additional study requested)
Libervant (diazepam) buccal film  Aquestive Management of seizure clusters 172 Decision delayed
Illuccix Telix Prostate cancer imaging 98 Approved
Xaciato
(DARE-BV1)
Dare Bioscience Bacterial vaginosis 28** Approved
Entadfi
(tadfin)
Veru Benign prostatic hyperplasia 18 Approved
Adbry (tralokinumab) Leo Pharma Atopic dermatitis - Approved
Brixadi Braeburn Opioid use disorder - CRL (deficiencies at 3rd party manufacturing facility)
Epsolay Sol-Gel Papulopustular rosacea - Pre-approval inspection set for February
LV-101 Levo Hyperphagia and behavioural distress associated with Prader-Willi syndrome - No decision yet; negative FDA panel meeting in November
*SBI not split out; **Includes undisclosed partner sales. ASCVD=clinical atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolaemia. Source: Evaluate Pharma & company releases.

 

 
Advisory committee meetings in December
Project Company Indication Outcome
Bardoxolone methyl Reata Chronic kidney disease caused by Alport syndrome 13-0 against approval
Source: Evaluate Pharma, FDA adcom calendar.

 

 
Supplementary and other notable approval decisions in December
Product Company Indication (clinical trial) Outcome
Yusimry (CHS-1420/
Humira biosimilar)
Coherus Plaque psoriasis, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, rheumatoid arthritis and Crohn's disease Approved
Keytruda  Merck & Co Adjuvant treatment stage IIB/C melanoma following complete resection (Keynote-716) Approved
Caplyta Intra-Cellular Therapies Bipolar disorder as monotherapy and adjunctive therapy (Study 402, 404) Approved
Otezla Amgen Mild-to-moderate plaque psoriasis (Advance) Approved
Orencia + calcineurin inhibitor + methotrexate Bristol Myers Squibb Prevention of acute graft versus host disease (ph2 ABA2) Approved
Oxbryta Global Blood Therapeutics Sickle cell disease in children ages 4-11, age-appropriate dispersible tablet dosage form Approved
Apretude (cabotegravir extended-release injectable suspension) Viiv (GSK/Pfizer/Shionogi joint venture) Long-acting injectable for HIV prevention, for use every two months (HPTN 083, HPTN 084) Approved
Xeljanz Pfizer Ankylosing spondylitis (A3921120) Approved
Rinvoq Abbvie Psoriatic arthritis (Select-PsA1 & Select-PsA2) Approved
Olumiant Lilly Atopic dermatitis (Breeze-AD programme) No decision yet
Kyprolis +
Darzalex Faspro
Amgen Adults with r/r multiple myeloma with 1-3 lines of previous therapy (Pleiades) Approved
Zynrelef Heron Soft tissue or periarticular instillation to product postsurgical analgesia in various surgical procedures Approved
Cutaquig Octapharma Paediatric pts aged ≥2 with primary humoral immunodeficiency  Approved
Rituxan + chemo Roche Children 6 months to <18 years with previously untreated, advanced CD20+ DLBCL, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukaemia (Inter-B-NHL Ritux) Approved
Xarelto J&J Treatment and prevention of blood clots in pts aged <18; prevention of blood clots in pts aged ≥2 with congenital heart disease who have had Fontan procedure  Approved
Cosentyx Novartis Children/adolescents with enthesitis-related & psoriatic arthritis (Junipera) Approved
Rexulti Otsuka Schizophrenia in pts aged ≥13 Approved
Rezvoglar (Lantus biosimilar) Eli Lilly

Adults and paediatric patients with type 1 diabetes and adults with type 2 diabetes

Approved
Source: Evaluate Pharma & company releases. 

 

 
FDA Covid-19 EUAs
Product Company Indication
Molnupiravir Merck & Co Treatment of high-risk adults with mild-to-moderate Covid-19, if no alternatives available or appropriate
Paxlovid Pfizer Treatment of high-risk pts aged ≥12 with mild-to-moderate Covid-19
Evusheld (AZD7442) Astrazeneca Pre-exposure prophylaxis in certain individuals
Source: Evaluate Pharma & company releases. 

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