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/ Astrazeneca	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/ Novartis	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
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. https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-july-2022