🧠 EU regulators recommended approval of weekly, self-administered gefurulimab for adults with AChR-Ab+ gMG
📊 In phase 3️⃣ PREVAIL:
🔹 MG-ADL difference vs placebo: −1.6 points (P <.001)
🔹 QMG difference: −2.1 points (P <.001)
🔗 Read more: www.neurologylive.com/view/gefurul...
#GMG #Neurology
📊 In phase 3️⃣ PREVAIL:
🔹 MG-ADL difference vs placebo: −1.6 points (P <.001)
🔹 QMG difference: −2.1 points (P <.001)
🔗 Read more: www.neurologylive.com/view/gefurul...
#GMG #Neurology
Gefurulimab Recommended for EU Approval in Generalized Myasthenia Gravis | NeurologyLive - Clinical Neurology News and Neurology Expert Insights
The CHMP recommended approval of gefurulimab (Klygefa), a weekly self-administered C5 inhibitor, for AChR-antibody-positive generalized myasthenia gravis in the EU.
www.neurologylive.com
September 22, 2026 at 1:11 PM
🧠 EU regulators recommended approval of weekly, self-administered gefurulimab for adults with AChR-Ab+ gMG
📊 In phase 3️⃣ PREVAIL:
🔹 MG-ADL difference vs placebo: −1.6 points (P <.001)
🔹 QMG difference: −2.1 points (P <.001)
🔗 Read more: www.neurologylive.com/view/gefurul...
#GMG #Neurology
📊 In phase 3️⃣ PREVAIL:
🔹 MG-ADL difference vs placebo: −1.6 points (P <.001)
🔹 QMG difference: −2.1 points (P <.001)
🔗 Read more: www.neurologylive.com/view/gefurul...
#GMG #Neurology
🟢 #$AZN — Regulatory Designation
EU CHMP Positive Opinion - Klygefa (gefurulimab) for AChR antibody-positive generalised myasthenia gravis
CHMP of the EMA recommended Klygefa (gefurulimab) for approval in the EU as an add-on to standard therapy for adults with g…
https://biostock.app/symbols/AZN
EU CHMP Positive Opinion - Klygefa (gefurulimab) for AChR antibody-positive generalised myasthenia gravis
CHMP of the EMA recommended Klygefa (gefurulimab) for approval in the EU as an add-on to standard therapy for adults with g…
https://biostock.app/symbols/AZN
September 21, 2026 at 12:56 PM
🟢 #$AZN — Regulatory Designation
EU CHMP Positive Opinion - Klygefa (gefurulimab) for AChR antibody-positive generalised myasthenia gravis
CHMP of the EMA recommended Klygefa (gefurulimab) for approval in the EU as an add-on to standard therapy for adults with g…
https://biostock.app/symbols/AZN
EU CHMP Positive Opinion - Klygefa (gefurulimab) for AChR antibody-positive generalised myasthenia gravis
CHMP of the EMA recommended Klygefa (gefurulimab) for approval in the EU as an add-on to standard therapy for adults with g…
https://biostock.app/symbols/AZN
#AstraZeneca's rare disease unit #Alexion has claimed a positive opinion from the #EMA's human medicines committee for #generalisedmyastheniagravis (gMG) therapy #Klygefa.
pharmaphorum.com/news/azs-gmg...
pharmaphorum.com/news/azs-gmg...
September 21, 2026 at 9:10 AM
#AstraZeneca's rare disease unit #Alexion has claimed a positive opinion from the #EMA's human medicines committee for #generalisedmyastheniagravis (gMG) therapy #Klygefa.
pharmaphorum.com/news/azs-gmg...
pharmaphorum.com/news/azs-gmg...
【gefurulimab、全身性重症筋無力症でCHMPが承認勧告】
AstraZenecaのKlygefa。対象はAChR抗体陽性の全身性重症筋無力症。第3相PREVAILで、26週時点のMG-ADLがプラセボより1.6改善した（95％CI −2.4〜−0.8）。勧告であり、承認ではない。
AstraZenecaのKlygefa、全身性重症筋無力症でCHMPが承認勧告──第3相PREVAIL試験でMG-ADLスコアが有意に改善
stellanews.life/technology/1...
AstraZenecaのKlygefa。対象はAChR抗体陽性の全身性重症筋無力症。第3相PREVAILで、26週時点のMG-ADLがプラセボより1.6改善した（95％CI −2.4〜−0.8）。勧告であり、承認ではない。
AstraZenecaのKlygefa、全身性重症筋無力症でCHMPが承認勧告──第3相PREVAIL試験でMG-ADLスコアが有意に改善
stellanews.life/technology/1...
AstraZenecaのKlygefa、全身性重症筋無力症でCHMPが承認勧告──第3相PREVAIL試験でMG-ADLスコアが有意に改善
Alexion（AstraZeneca Rare Disease）のgefurulimab（Klygefa）が、AChR抗体陽性の全身性重症筋無力症（gMG）を対象にEUでのCHMP承認勧告を取得した。第3相PREVAIL試験で主要評価項目を達成している。
stellanews.life
September 20, 2026 at 5:55 AM
【gefurulimab、全身性重症筋無力症でCHMPが承認勧告】
AstraZenecaのKlygefa。対象はAChR抗体陽性の全身性重症筋無力症。第3相PREVAILで、26週時点のMG-ADLがプラセボより1.6改善した（95％CI −2.4〜−0.8）。勧告であり、承認ではない。
AstraZenecaのKlygefa、全身性重症筋無力症でCHMPが承認勧告──第3相PREVAIL試験でMG-ADLスコアが有意に改善
stellanews.life/technology/1...
AstraZenecaのKlygefa。対象はAChR抗体陽性の全身性重症筋無力症。第3相PREVAILで、26週時点のMG-ADLがプラセボより1.6改善した（95％CI −2.4〜−0.8）。勧告であり、承認ではない。
AstraZenecaのKlygefa、全身性重症筋無力症でCHMPが承認勧告──第3相PREVAIL試験でMG-ADLスコアが有意に改善
stellanews.life/technology/1...
Klygefa®: A New Hope for Adults with Generalized Myasthenia Gravis in Japan#Japan#Myasthenia_Gravis#Minato-ku,_Tokyo#Klygefa#Alexion_Pharma
Klygefa®: A New Hope for Adults with Generalized Myasthenia Gravis in Japan
Klygefa® has been approved in Japan as a treatment for adults with generalized myasthenia gravis, offering a new self-administered option for patients.
third-news.com
September 16, 2026 at 6:39 AM
Klygefa®: A New Hope for Adults with Generalized Myasthenia Gravis in Japan#Japan#Myasthenia_Gravis#Minato-ku,_Tokyo#Klygefa#Alexion_Pharma