US FDA approval tracker: April

Snippets

Last month was loaded with US FDA knockbacks and delays. Reviews of four Jak inhibitors – abrocitinib, Xeljanz, Olumiant and Rinvoq – were pushed back until the third quarter, apparently on ongoing toxicity concerns with the class. Manufacturing inspection issues also rumbled on, resulting in a delay for Sol-Gel’s rosacea cream Epsolay and a CRL for Protalix’s Fabry candidate pegunigalsidase alfa. Meanwhile, the FDA’s adcom on accelerated approvals for anti-PD-(L)1 drugs gave positive votes for four of six indications discussed. The panel pushed back against Keytruda’s use in late-line gastric cancer and Opdivo’s in second-line liver cancer. Separately, Glaxosmithkline’s own anti-PD-L1 MAb Jemperli finally gained accelerated approved in second-line mismatch repair-deficient endometrial cancer, after a five-month delay caused by Covid-19 travel restrictions.

Notable first-time US approval decisions in April
Project Company 2026e sales by indication ($m) Outcome
Abrocitinib
(PF-04965842)
Pfizer 1,127 Decision extended to early Q3
Zynlonta (loncastuximab tesirine) ADC Therapeutics 1,025 Approved (accelerated) ~1 mth early
Jemperli
(dostarlimab)
Glaxosmithkline 546 Approved (accelerated)
Eohilia
(TAK-721)
Takeda 350 No decision yet
Oral sulopenem etzadroxil Iterum 329 FDA needs more time to review filing, 2 Jun adcom postponed
IV Tramadol Avenue 273 No decision yet
Qelbree
(SPN-812)
Supernus 265 Approved
Tanezumab Pfizer/Lilly 155 No decision yet
Epsolay Sol-Gel - Delayed (manufacturing inspection)
Pegunigalsidase alfa Protalix - CRL (manufacturing inspection)
Adtralza (tralokinumab) Leo Pharma - CRL
Nextstellis
(Estelle)
Mithra/Mayne Pharma Group - Approved
Teplizumab Provention Bio - Deficiencies in filing, 27 May adcom
Source: Evaluate Pharma & company releases.
 
Advisory committee meetings in April
Project Company  2026e sales by indication ($m) Note Outcome
Donislecel Celltrans - Allogeneic islets of Langerhans for transplant, for type 1 diabetes Positive
Tecentriq, Keytruda,
Opdivo
Roche, Merck, Bristol - Six indications given accelerated approval where confirmatory studies have failed Four positive, two negative (Dangling PD-1s emerge strong from three-day grilling)
Sources: FDA adcom calendar & Evaluate Pharma.
 
Supplementary and other notable approval decisions in April
Product Company Indication (clinical trial) Outcome
Subcutaneous Tysabri Biogen Relapsing-remitting MS (Deliver, Refine) CRL
Nuplazid Acadia Dementia-related psychosis (Harmony) CRL
Tyvaso United Therapeutics Pulmonary hypertension associated with interstitial lung disease (Increase) Approved
Praluent Sanofi/
Regeneron
Homozygous familial hypercholersterolaemia (Odyssey HoFH) Approved
Farxiga Astrazeneca CKD with or without type 2 diabetes (Dapa-CKD) Approved
Erbitux Merck KGaA/
Lilly
Biweekly dosing regimen Approved
Trodelvy Gilead Advanced or metastatic urothelial cancer (Trophy) Approved (accelerated)
Xolair Roche/Novartis Self-administration option across all approved US indications Approved
Opdivo Bristol Plus chemotherapy, gastric/gastroesophageal junction cancer & oesophageal adenocarcinoma (Checkmate-649) Approved
Nurtec ODT Biohaven Migraine prevention (Study 305, 201) No decision yet
Alecensa Roche 1st-line Alk-positive NSCLC (Bfast) No decision yet
Xeljanz Pfizer Ankylosing spondylitis (A3921120) Extended to early Q3
Olumiant  Lilly Atopic dermatitis (Breeze-AD program) Extended to early Q3
Rinvoq Abbvie Atopic dermatitis (Measure Up 1, Measure Up 2, AD Up) Extended to early Q3
(decision in psoriatic arthritis previously extended to late Q2)
Ibsrela (tenapanor) Ardelyx Control of serum phosphorus in patients with CKD on dialysis (Amplify, Phreedom, Block) Extended to 29 Jul
Source: Evaluate Pharma & company releases.

 

Accelerated approval decisions - full approval/withdrawn (study)
Product Company Outcome
Trodelvy Gilead Full approval mTNBC (Ascent)
 
FDA EUAs to treat Covid-19
Product Company Outcome
Bamlanivimab monotherapy Lilly Revoked

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