FDA approval tracker: June

 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. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-june-0