US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Shots: Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…

ByDipanshu DixitAugust 14, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2024 The US FDA approved a total of 2 new drugs including 1 new molecular entity and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Eli Lilly’s Kisunla for…

ByDipanshu DixitAugust 13, 2024

NEWS

Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)

Shots: The approval of Nemluvio (SC pre-filled pen) was based on P-III (OLYMPIA 1 & 2) studies assessing its safety & efficacy vs PBO in PN patients (n= >500) Studies met their 1 & 2EPs, showing at least a 4-point reduced itch intensity in 56% & 49% vs 16% (both PBO groups); skin nodules clearance…

ByDipanshu DixitAugust 13, 2024

NEWS

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration

Shots: The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…

ByDipanshu DixitAugust 12, 2024

NEWS

Ascendis Pharma’s Yorvipath Receives the US FDA’s Approval to Treat Hypoparathyroidism

Shots: The US FDA has approved Yorvipath (QD) tablets for treating hypoparathyroidism patients, with its initial supply planned during Q1’25 The approval was supported by the P-II (PaTH Forward) as well as P-III (PaTHway) clinical trials conducted worldwide Ascendis will further introduce the US Ascendis Signature Access Program (A.S.A.P.) for treatment support & financial assistance…

ByDipanshu DixitAugust 9, 2024

NEWS

The US FDA Approves Citius Pharmaceuticals’ Lymphir to Treat R/R Cutaneous T-Cell Lymphoma (CTCL)

Shots: The US FDA has granted approval to Lymphir for treating chronic r/r CTCL in patients treated with at least one prior systemic therapy, with its introduction anticipated within the next 5mos. The approval was based on P-III (Study 302) trial assessing the safety & efficacy of Lymphir (9mcg/kg, IV) among patients (n=69) with…

ByDipanshu DixitAugust 8, 2024

NEWS

Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after…

ByDipanshu DixitAugust 6, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of July 2024

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…

ByDipanshu DixitAugust 1, 2024

INSIGHTS+

New Drug Designations – June 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…

BySenior EditorJuly 30, 2024

NEWS

Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata

Shots: The US FDA has granted approval to the company’s Leqselvi (8mg) tablets for treating severe alopecia areata adults Approval was supported by two P-III (THRIVE-AA1 & THRIVE-AA2) studies that assessed the scalp hair regrowth using the SALT score with Leqselvi (8mg or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata…

ByDipanshu DixitJuly 25, 2024

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Insights+: The US FDA New Drug Approvals in July 2024

Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)

Ascendis Pharma’s Yorvipath Receives the US FDA’s Approval to Treat Hypoparathyroidism

The US FDA Approves Citius Pharmaceuticals’ Lymphir to Treat R/R Cutaneous T-Cell Lymphoma (CTCL)

Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Insights+ Key Biosimilars Events of July 2024

New Drug Designations – June 2024

Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata

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