Adalimumab-ATTO(Amgen)

Drugs from Amgen, GSK join TrumpRxBioMarin stops certain skeletal studies after safety signalLilly's Ebglyss passes paediatric testDrugs from Amgen, GSK join TrumpRxTrumpRx, a direct-to-consumer (DTC) platform run by the US government, welcomed three new products to its site on Monday, according to a post on X from the White House. Amgen is offering its migraine medicine Aimovig (erenumab), as well as Amjevita (adalimumab-atto) — its biosimilar of AbbVie's Humira (adalimumab) — for a monthly cash-pay price of $299 each. GSK's Incruse Ellipta (umeclidinium), an inhaled treatment for chronic obstructive pulmonary disease (COPD), is available for $159.20 per month on TrumpRx for self-pay patients. The three additions to TrumpRx come after the website officially launched in February with price cuts for about 43 medications.Both pharmas, along with seven other drugmakers, agreed in December to sell some of their products on DTC sites as part of a most favoured nation drug pricing agreement with the Trump administration. -Elizabeth EatonBioMarin stops certain skeletal studies after safety signalBioMarin disclosed in a securities filing Monday that, following a safety signal in a pair of investigator-sponsored trials, it has halted its own Phase II studies evaluating Voxzogo (vosoritide) in patients with certain skeletal conditions. The drugmaker said that "several" cases of slipped capital femoral epiphysis (SCFE) occurred in the investigator-sponsored trials. As a result, it will discontinue dosing and enrollment in its studies involving patients with Turner syndrome, SHOX-deficiency and ACAN-deficiency. BioMarin emphasised that SCFE events have not been observed in its trials of these indications, nor in any of its achondroplasia or hypochondroplasia studies. The Phase II CANOPY trial evaluating Voxzogo in children with Noonan syndrome, as well as those living with idiopathic short stature (ISS) without ACAN-deficiency, will continue unaffected. The FDA approved Voxzogo for achondroplasia in 2021; since then, the company has made expanding the modified C-type natriuretic peptide's label into additional skeletal conditions central to its growth strategy. Before Monday's setback, BioMarin had been targeting five new indications for Voxzogo by 2031, including hypochondroplasia, ISS, Noonan syndrome, Turner syndrome and SHOX deficiency. -Elizabeth EatonLilly's Ebglyss passes paediatric testEli Lilly's Ebglyss (lebrikizumab-lbkz) met the primary and key secondary endpoints of the Phase III ADorable-1 trial in paediatric patients with moderate-to-severe atopic dermatitis. The company plans to submit the data to the FDA and other regulators for a potential update to the IL-13 inhibitor's label.Top-line results showed that 63% of patients on Ebglyss achieved meaningful skin improvement at week 16, as measured by a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline, and 44% achieved clear or almost clear skin on the Investigator's Global Assessment (IGA). For patients taking placebo, 22% achieved EASI-75 and 15% had clear or almost clear skin based on IGA."Ebglyss has already changed what's possible for adults and adolescents," said Adrienne Brown, president of Lilly Immunology. "Now, these data show Ebglyss also provided disease control in paediatric patients."The company has rights to Ebglyss in all markets, except Europe, where Almirall has licensed rights for all dermatology indications, including atopic dermatitis.-Matthew Dennis