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 only 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.  https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/us-fda-approval-tracker-december