US FDA approval tracker: May

The most valuable approval of the year was bestowed in May − that of Lilly’s Mounjaro in type 2 diabetes. According to Evaluate Pharma its consensus 2028 forecasts are over $8bn, and the product is gearing up to take market share from Novo’s diabetes franchise. Elsewhere it was good news for Dupixent as the anti-IL-4/1L-13 MAb became the first FDA-approved drug for the chronic inflammatory disease eosinophilic oesophagitis (EoE). The decision for Sanofi/Regeneron’s product came over two months early. Competing data from Astrazeneca’s phase 3 Messina study testing the anti-IL-5 MAb Fasenra in EoE are expected in the second half of the year. It was not all good news last month: UCB and Verrica both received knockbacks, while Avadel, Amicus and Pfizer/Myovant all had their Pdufas extended. On the theme of delays, TG Therapeutics became the latest to suffer a three-month extension, announcing yesterday that the Pdufa for ublituximab in relapsing multiple sclerosis had been pushed out to the end of December. This came after a long list of setbacks for the company.

Notable first-time US approval decisions in May
Project Company Indication(s) 2028e sales by indication (SBI) ($m) Outcome
Mounjaro
(tirzepatide)
Lilly Type 2 diabetes 8,132 Approved
Bimzelx UCB Plaque psoriasis 1,191 CRL (pre-approval inspections)
AXS-05 Axsome Major depressive disorder 787 Pending (Q2)
FT218 Avadel Treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy 361 Full approval not expected until mid-2023, when Jazz's '963 REMS patent expires
VP-102 Verrica Molluscum contagiosum 359 CRL (deficiencies at CMO)
Miglustat Amicus Pompe disease 266* Delayed to Aug 29 (cipaglucosidase Pdufa also delayed to Oct 29, combination product known as AT-GAA)
Vtama (tapinarof) Dermavant Plaque psoriasis - Approved
Annik (penpulimab) Akeso/Sino 3L nasopharyngeal carcinoma - Pending (H1)
Voquenza triple pak, Voquenza dual pak
(vonoprazan)
Phathom Adults with H pylori infection - Approved
Radicava ORS (MT-1186, oral edaravone) Mitsubishi Tanabe ALS - Approved
Lamotrigine (ET-105) for supspension Eton/Azurity Epilepsy - CRL
*Forecasts for AT-GAA. Source: Evaluate Pharma & company releases.

 

Supplementary and other notable approval decisions in May
Product Company Indication (clinical trial) Outcome
Myfembree Pfizer/Myovant Moderate to severe pain associated with endometriosis (Spirit 1, Spirit 2) Delayed to Aug 6 (FDA needs more time to review bone mineral density information)
Tyvaso DPI Mannkind/United Therapeutics PAH and pulmonary hypertension-associated interstitial lung disease  Approved
Evrysdi Roche/PTC Pre-symptomatic infants under 2 months old with spinal muscular atrophy (Rainbowfish) Approved
Opdivo + Yervoy, Opdivo + chemo Bristol Myers Squibb 1L unresected advanced, recurrent or metastatic oesophageal squamous cell carcinoma (Checkmate-648) Approved
Enhertu Astra/Daiichi Her2+ve breast cancer after anti-Her2-therapy (Destiny-Breast 03) Approved
Olumiant Lilly Treatment of certain hospitalised patients with Covid-19 Approved
Kymriah Novartis 3L follicular lymphoma (ph2 Elara) Approved
Tpoxx IV Siga Smallpox Approved
Dupixent Sanofi/Regeneron Eosinophilic oesophagitis, 12 years and older (NCT03633617) Approved (over 2mth early)
Annovera Therapeutics MD Birth control, revisions to in vitro release testing specification Approved
Vidaza Bristol Myers Squibb Paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia (AZA-JMML-001) Approved
Tibsovo + Vidaza Servier Newly diagnosed IDH1-mutated AML in adults 75 years or older (Agile) Approved
Fylnetra
(Neulasta biosimilar)
Amneal Neutropenia Approved
Beovu Novartis Diabetic macular oedema (Kestrel, Kite) Approved
Source: Evaluate Pharma & company releases.

 

FDA Covid-19 EUAs
Product Company Outcome
Janssen Covid-19 vaccine 
(Ad26.COV2-S)
J&J Authorised use limited to individuals aged 18+ for whom other authorised or approved vaccines are not accessible or clinically appropriate, and to individuals aged 18+ who elect to receive the J&J vaccine because they would otherwise not receive a vaccine (received EUA in Feb 21)
Comirnaty Pfizer/
Biontech
Single booster dose authorised for individuals aged 5-11
Source: company releases.

 

The supplementary table has been updated to include Beovu's approval.

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