
US FDA approval tracker: April 2021
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 |