US FDA approval tracker: June

Snippets

Last month the US regulator gave a controversial thumbs-up to Biogen’s Alzheimer’s drug Aduhelm, and the decision boosted the company’s market cap by $16.5bn. The approval was given on the condition that a confirmatory trial be run, but remarkably the study is not required to read out until 2030 at the latest. Aduhelm’s approval opened the floodgates in Alzheimer’s and Eli Lilly has confirmed it intends to file its similarly acting donanemab later this year. Elsewhere, three complete response letters were dished out, including one for Orphazyme’s arimoclomol in Niemann-Pick disease, with the FDA requesting further clinical data. The Pdufa for Ascendis’s paediatric growth hormone deficiency treatment TransCon hGH was extended; three other decisions were also delayed. The agency also missed the deadline for Abbvie's Rinvoq in two indications owing to ongoing safety concerns with the Jak class. Delays for other Jak inhibitors will likely continue into the next few months as the regulator continues to review the safety profile of Pfizer's Xeljanz (Go or no go? Ardelyx and Chemocentryx among those waiting FDA decisions, July 1, 2021).

Notable first-time US approval decisions in June
Project Company Indication(s)  2026e sales by indication ($m) Outcome
Aduhelm
(aducanumab)
Biogen/Eisai Alzheimer's disease 3,907 Approved (accelerated)
Transcon hGH
(lonapegsomatropin)
Ascendis Paediatric growth hormone deficiency 1,407 Extended to Sept 25
PF-06482077/
20vPnC/ Prevnar 20
Pfizer Pneumonia 1,037 Approved
Lybalvi
(ALKS 3831)
Alkermes Schizophrenia and bipolar I disorder 380 Approved
Eohilia/
TAK-721
Takeda Eosinophilic esophagitis 350 No decision yet

Brexafemme (ibrexafungerp/SCY-078)

Scynexis Vulvovaginal candidiasis  302 Approved
Miplyffa (arimoclomol) Orphazyme Niemann Pick disease type C 297 CRL (more data needed)
IV Tramadol Avenue Acute pain 273 CRL (second)
VP-102 Verrica Molluscum contagiosum 271 Extended to Sept 23
Nexobrid Mediwound/
Vericel
Treatment of severe thermal burns 165 CRL (CMC)
Tanezumab Pfizer/Lilly Moderate-to-severe osteoarthritis pain 155 No decision yet
Ryplazim Liminal Congenital plasminogen deficiency 66 Approved
StrataGraft Mallinckrodt Adults with deep partial-thickness thermal burns 59 Approved
Rylaze
(JZP-458)
Jazz Component of chemo regimen to treat ALL or lymphoblastic  lymphoma in patients who are allergic to  E. coli-derived asparaginase  33 Approved
Rezipres (Ephedrine injection/ET-203) Eton/Sintetica Hypotension 37 Approved
Verkazia Santen Keratoconjunctivitis in patients aged 4-18 - Approved
Tembexa
(brincidofovir)
Chimerix Smallpox (adult and paediatric patients) - Approved (~1 month early)
Source: Evaluate Pharma & company releases.

 

Advisory committee meetings in June
Project Company Adcom date Indication 2026e sales by indication ($m) Outcome Note
Retifanlimab
(INCMGA0012)
Incyte/Macrogenics June 24 Adult patients with locally advanced or met squamous carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy. 53 13-4 voted for confirmatory study Anti-PD-1 MAb, Pdufa July 25
Source: Evaluate Pharma & FDA adcom calendar.
 
 
Supplementary and other notable approval decisions in June
Product Company Indication (clinical trial) Outcome
Rinvoq Abbvie Psoriatic arthritis (Select-PsA 1, Select-PsA 2) Missed (FDA citing review of Pfizer's Xeljanz)
Rinvoq Abbvie Ankylosing spondylitis (Select-Axis 1) Missed (FDA citing review of Pfizer's Xeljanz)
Ruxolitinib cream Incyte Atopic dermatitis (TruE-AD1, TruE-AD2 Extended to Sept 21
Jakafi Incyte/Novartis Paediatric patients with steroid-refractory GVHD (Reach3) Extended to Sept 22
Cosentyx Novartis Moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years (NCT03668613, NCT02471144) Approved
Ultomiris Astrazeneca Children and adolescents with PNH Approved
Trikafta Vertex Children aged 6 to 11 who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data (NCT03691779) Approved
Ayvakit Blueprint Advanced systemic mastocytosis (Pathfinder, Explorer) Approved
Solosec Lupin Treatment of trichomoniasis  in adults and adolescents Approved
Wegovy (semgalutide 2.4mg) Novo Nordisk Obesity (Step 1, 2, 3, 4) Approved
Epclusa Gilead Expansion of the paediatric indication for chronic hepatitis C (NCT03022981) Approved
Pradaxa (oral pellets) Boehringer Ingelheim Blood thinner for children aged 3 months to less than 12 years old (NCT01895777, NCT02197416) Approved
Alecensa Roche 1st-line Alk-positive NSCLC (Bfast) No decision yet
Source: Evaluate Pharma & company releases.

 

FDA Covid-19 EUAs
Product Company 2026e sales by indication ($m) Note
Actemra Roche - Treatment of hospitalized adults and paediatric patients
Source: Evaluate Pharma & company releases.

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