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Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively
In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…
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The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.
Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…
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Kali Therapeutics has entered into a license agreement with Sanofi for KT501 to treat a broad range of B cell-mediated autoimmune diseases
As per the deal, Sanofi will obtain exclusive worldwide rights to KT501, while Kali will receive upfront & near-term payments totaling $180M and up to $1.05B in development & commercial milestones, with tiered royalties…
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The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3)
Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS
Venglustat received US…
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Sino Biopharm via its subsidiary Chia Tai Tianqing has entered into an exclusive license agreement with a fully owned subsidiary of Sanofi for rovadicitinib
As per the deal, Sanofi will obtain exclusive global license to develop, manufacture & commercialize rovadicitinib in exchange for $135M upfront & ~$1.395B in development, regulatory & sales milestones, as…
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FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts
Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…
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Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study
Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…
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Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3
Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…
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The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks.
Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…
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China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control
The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…

