US FDA approval tracker: March

March proved to be a busy month at the FDA, with success for Novartis’s second radioligand product and the ushering in of three first-in-class drugs: Marinus’s Ztalmy, CTI Biopharma’s Vonjo, and Bristol Myers Squibb's Opdualag. The final product on the list is a combination of Opdivo and relatlimab, the first Lag3 inhibitor to pass the regulator. Bristol might be hoping that relatlimab’s reduced toxicity will allow it in time to swap out Yervoy in combination treatments. Meanwhile, approval of Novartis’s Pluvicto in patients with metastatic castration-resistant prostate cancer after androgen receptor blockade plus chemo looks to have provided some justification of the Swiss group’s $2.1bn acquisition of Endocyte in 2018. On the other side of the coin, those facing disappointment last month included Akebia, and Lilly and its Chinese partner Innovent. Akebia fell foul of FDA concerns around thromboembolic events and toxicity, which have hit others in the HIF-PH inhibitor space, while Lilly/Innovent’s chances of approval for the PD-1 antibody Tyvyt were doomed after a 14-1 advisory committee vote against.

Notable first-time US approval decisions in March
Project Company Indication(s) 2026e sales by indication ($m) Outcome
Pluvicto
(177Lu-PSMA-617)
Novartis Radioligand therapy for mCRPC 851 Approved
U2 combination
(Ukoniq + ublituximab) 
TG Therapeutics Chronic lymphocytic leukaemia and small lymphocytic lymphoma 691 Adcom Apr 22, Pdufa extended to Jun 25
Vadadustat Akebia/
Vifor/
Otsuka
Anaemia due to CKD in adult patients on/not on dialysis CRL (toxicity concerns, new pivotal study required)
Vonjo
(pacritinib)
CTI Biopharma Myelofibrosis 469 Approved
Opdualag (relatlimab + Opdivo) Bristol Myers Squibb 1L melanoma 437 Approved
Ztalmy (ganaxolone) Marinus Seizures associated with CDKL5 deficiency disorder (rare form of genetic epilepsy) 384* Approved

Botulax (LetibotulinumtoxinA)

Hugel America Moderate to severe glabellar lines 245 CRL
Tyvyt
(sintilimab)
Lilly/
Innovent
1L nonsquamous NSCLC CRL (mutliregional study required, non-inferiority design against SoC)
Source: Evaluate Pharma & company releases. *SBI as general epilepsy.

 

Advisory committee meetings in March
Project Company Indication Peak sales (non-risk adjusted, $m) Outcome
AMX0035 (sodium phenylbutyrate + taurursodiol) Amylyx ALS 1,820 6-4 against approval 
Source: broker reports (pre adcom) & FDA adcom calendar.

 

Supplementary and other notable approval decisions in March
Product Company Indication (clinical trial) Outcome
Cabenuva Glaxo/Viiv/ J&J Treatment of HIV-1 in virologically suppressed adolescents who are 12 years of age or older and weigh at least 35kg (Mocha) Approved
Triumeq PD Glaxo/Viiv Dispersible tablet formulation for the treatment of paediatric patients with HIV, and minimum weight required for tablet form lowered to 25kgs Approved
Adlarity
(donepezil  transdermal system)
Corium Dementia due to mild, moderate, or severe Alzheimer's disease Approved
Fintepla Zogenix/ UCB Seizures associated with Lennox-Gastaut Syndrome Approved
Reblozyl Bristol/ Merck & Co Anaemia in adults with non-transfusion-dependent beta-thalassemia (ph2 Beyond) Delayed to Jun 27 (information request)
Keytruda Merck 2nd-line MSI-H/dMMR endometrial cancer (Keynote-158, cohorts D & K) Approved
Tlando Lipocine/
Antares
Oral testosterone replacement therapy Approved (final approval, received tentative decision in December)
Lynparza Astrazeneca Adjuvant BRCA-mutated Her2 -ve breast cancer (OlympiA) Approved
Ozempic (2.0mg) Novo Nordisk Type 2 diabetes (Sustain Forte) Approved
Fasenra Astrazeneca Inadequately controlled chronic rhinosinusitis with nasal polyps (Ostro) CRL (additional data requested)
Rinvoq Abbvie Ankylosing spondylitis and ulcerative colitis  Approved in UC
Opdivo + chemo Bristol Neoadjuvant stage IB-IIIA NSCLC all-comers (Checkmate-816) Approved (~4 months early)
Releuko
(filgrastim biosimilar)
Kashiv/
Amneal
Treatment and prevention of febrile neutropenia Approved (third filgrastim biosim approved by the FDA)
Source: Evaluate Pharma & company releases.

 

US EUAs to treat Covid-19
Project Company Setting Outcome
Covaxin Ocugen/ Bharat
Biotech
Prevent Covid-19 in individuals aged 2-18 years old Declined
Spikevax
(mRNA-1273)
Moderna Second booster dose in adults aged 50 and older, and ≥18 if immunocompromised Approved
Comirnaty Pfizer Second booster dose in adults aged 50 and older, and ≥12 if immunocompromised Approved
Source: company releases.

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