US FDA approval tracker: January 2022

Roche’s bispecific antibody Vabysmo swayed the regulators last month, but now has to make headway in a competitive space dominated by Regeneron and Bayer’s Eylea. Vabysmo was approved for both wet age-related macular degeneration and diabetic macular oedema, with Roche hoping to exploit the therapy's less frequent dosing. However, Regeneron/Bayer have their defences ready: data on a higher dose version of Eylea are due in the second half of the year. Elsewhere the FDA dished out complete response letters for Pfizer/Opko’s somatrogon and Merck & Co’s gefapixant. The latter is a P2X3 receptor antagonist being tested in chronic cough, and the knockback came as regulators requested further information on efficacy. Bellus Health’s competing project BLU-5937 has had its ups and downs in early trials, but phase 3 will be the real test, with studies due to start this year.  

Notable first-time US approval decisions in January
Project Company Indication(s) 2026e sales by indication ($m) Outcome
Spikevax Moderna Prevention of Covid-19 (18 years of age and older)  3,686 Approved (gained EUA Dec 2020)
Vabysmo (faricimab) Roche wAMD, DME 1,129 Approved
177Lu-PSMA-617  Novartis Radioligand therapy for mCRPC 851 No decision yet, guided to H1
Cibinqo Pfizer Atopic dermatitis 760 Approved
Quviviq (daridorexant) Idorsia Insomnia 531 Approved
Somatrogon
(hGH-CTP)
Pfizer/Opko Growth hormone deficiency 113 CRL
Oteseconazole
(VT-1161)
Mycovia Recurrent vulvovaginal candidiasis - Not yet disclosed
Zonisamide oral suspension Azurity/Eton Partial seizures in patients with epilepsy - Not yet disclosed
Ryaltris nasal spray Glenmark/
Hikma
Seasonal allergic rhinitis - Approved
(CRL in 2019)
LV-101 (intranasal carbetocin) Levo Therapeutics Hyperphagia, anxiousness, and distress associated with Prader-Willi syndrome - CRL
Gefapixant Merck Refractory chronic cough or unexplained chronic cough in adults - CRL (additional info related to efficacy)
Kimmtrak (Tebentafusp/IMCgp100) Immunocore HLA-A*02:01-positive unresectable or metastatic uveal melanoma  - Approved (~1 month early)
Source: Evaluate Pharma & company releases.
 
 
Supplementary and other notable approval decisions in January  
Product Company Indication (clinical trial) Outcome
Lynparza Astrazeneca Adjuvant Brca-mutated Her2-negative breast cancer (OlympiA) No decision yet, guided to Q1
Fasenra Astrazeneca Nasal polyps No decision yet, guided to H1
Vonvendi Takeda

Adult patients living with severe Type 3 von Willebrand disease

Approved
Cabenuva GSK/Viiv Every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults (Atlas-2M) Approved
Rinvoq Abbvie Refractory, moderate to severe atopic dermatitis in adults and children aged 12 and over (Measure Up 12, AD Up) Approved
Skyrizi Abbvie Active psoriatic arthritis (Keepsake-1 & Keepsake-2) Approved
Veklury Gilead Certain non-hospitalised adults and paediatric patients for the treatment of mild-to-moderate Covid Approved
Olumiant Lilly Atopic dermatitis (Breeze-AD programme) Potential for CRL
Libtayo Regeneron/
Sanofi
Recurrent/met cervical cancer whose disease progressed on or after chemotherapy (Empower-Cervical 1) Withdrawn
Source: Evaluate Pharma & company releases. 

This story has been updated to include the CRL for Levo's LV-101.

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