Alopecia

Woman experiencing hair loss
#Alopecia #CHMP #Regulatory

CHMP adopts positive opinion for severe alopecia treatment 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a treatment for severe alopecia.  The recommended approval of upadacitinib is for the treatment of adult and adolescent patients with severe alopecia areata (AA), an unpredictable autoimmune disease causing a… Read More

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Alopecia
#Absci #Alopecia #Clinical trial

Absci reports positive data from Phase I alopecia trial 

Biopharmaceutical company Absci has reported positive data from the Phase I trial of its alopecia treatment.  ABS-201, an investigational anti-prolactin receptor (PRLR) antibody, was evaluated in a first-in-human, randomised, double-blind, placebo-controlled study in 32 healthy volunteers with and without androgenetic alopecia (AGA).  The medication proved to be well-tolerated across… Read More

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Approval stamp
#Alopecia #Alys Pharmaceuticals #Clinical trials #FDA #Health Canada #Investigational New Drug (IND)

Clearance for first genetic medicine programme in dermatology

The US Food and Drug Administration (FDA) and Health Canada have cleared Alys Pharmaceuticals’ Investigational New Drug (IND) / Clinical Trial Application (CTA) for the study of ALY-101 in patients suffering from Alopecia Areata (AA). The Phase IIa trial will evaluate the safety and efficacy of ALY-101, an intradermal injectable… Read More

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Woman experiencing hair loss
#Alopecia #Hair loss #Pelage Pharmaceuticals #Phase II trial

‘Molecular switch’ could reverse the effects of alopecia

A Phase IIa clinical trial has begun evaluating the safety and efficacy of Pelage Pharmaceuticals’ PP405, a novel topical small molecule, for the treatment of androgenetic alopecia (pattern baldness). The company is enrolling 60 women and men for the clinical study. PP405 is designed to reactivate… Read More

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Alopecia
#Alopecia #Dermatology #Hair loss #JAK inhibitor #MHRA

First oral therapy for severe alopecia areata approved in UK

The MHRA has granted marketing authorisation for Eli Lilly’s baricitinib (Olumiant), the first licensed JAK inhibitor for the treatment of severe alopecia areata in adult patients.   The authorisation was based on BRAVE-AA1 and BRAVE-AA2 studies which both met the primary endpoint of the proportion of patients… Read More

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