US FDA approval tracker: July 2022

For companies that did not receive approval decisions in July, as expected, investors will hope that the old adage that no news is good news rings true. After the FDA provided proposed labelling in June the wait continues for Axsome’s AXS-05 in major depressive disorder. The verdict was originally scheduled for nearly a year ago and was first delayed by deficiencies. Neither has any update emerged on Akeso and Sino’s anti-PD-1 MAb penpulimab, which had an assumed first-half timing. Beigene, like Akeso, is based in China and review of its own anti-PD-1 MAb tislelizumab was postponed because Covid-related travel restrictions delayed inspections. Several drugs did manage to make it across the FDA line, though, including two dermatology thumbs-ups. Arcutis’s Zoryve, a topical PDE4 inhibitor, is now approved in plaque psoriasis, and Incyte’s Opzelura, a topical version of ruxolitinib, the active ingredient in Jakafi, became the first FDA-approved product for repigmentation in vitiligo.

Notable first-time US approval decisions in July
Project Company Indication(s) 2028e sales by indication ($m) Outcome
AXS-05 Axsome Major depressive disorder 787 Pending
Zoryve (roflumilast cream) Arcutis/
Plaque psoriasis in patients 12 years of age or older 606 Approved
Lumryz (FT218) Avadel Treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy 361 Tentative approval (full approval not expected until Jun 2023, when Jazz's '963 Rems patent expires)
Tislelizumab Beigene/
2nd-line oesophageal squamous cell carcinoma 83 Deferred owing to Covid-19 travel restrictions delaying inspections
Zonisade (zonisamide oral suspension) Eton Partial seizures in patients with epilepsy - Approved
Ryzneuta Evive Biotech (private) Chemotherapy-induced neutropenia - Pending (filed May 2021)
SH-111 Shorla Oncology (private) T-cell leukaemia - Pending (filed Apr 2021)
Annik (penpulimab) Akeso/Sino 3L nasopharyngeal carcinoma - Pending (was estimated as H1)
SBI: sales by indication. Source: company releases & Evaluate Pharma.


Supplementary and other notable approval decisions in July
Product Company Indication (clinical trial) Outcome
Stelara J&J Paediatric patients six years of age and older with active psoriatic arthritis (Pstellar, CadmusCadmus Jr) Approved
Krystexxa + methotrexate  Horizon Uncontrolled gout (Mirror) Approved
Opzelura (ruxolitinib cream)   Incyte Adolescents and adults with vitiligo (True-V1, True-V2) Approved
Comirnaty Pfizer/Biontech Immunisation to prevent Covid-19 in individuals aged 12-15 years of age (received EUA in May 2021) Approved
Xalkori Pfizer Adult and paediatric patients 1 year of age and older with unresectable, r/r inflammatory ALK-positive myofibroblastic tumours (ADVL0912, A8081013) Approved
Benlysta GSK Children aged 5-17 with active lupus nephritis Approved
Ronapreve (Regen-Cov) Regeneron Treatment of Covid-19 in non-hospitalised patients and as prophylaxis in certain individuals; given EUA in Nov 2020, limited Jan 2022 after emergence of omicron (NCT04425629, NCT04452318) Review said to be ongoing
Imfinzi + chemo  Astrazeneca 1L biliary tract cancer (Topaz-1) Pending (Q3)
Enhertu Astra/Daiichi Sankyo Unresectable or metastatic NSCLC whose tumours have a Her2 mutation and who have received prior systemic therapy (Destiny-Lung01) Pending (Q3)
Actemra Roche Hospitalised Covid patients; received EUA in Jun 2021 (Empacta, Covacta, Remdacta, Recovery) Pending (Q3)
Source: company releases & Evaluate Pharma.


FDA Covid-19 EUAs
Product Company Outcome
Zyesami NRX Pharmaceuticals Declined for subgroup of patients with critical Covid-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir
Nuvaxovid Novavax Granted for individuals 18 years of age and older (vaccine)
Source: company releases.

The supplemental table has been updated to include the paediatric approval of Stelara.

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