Shots:
The US FDA has approved Ebglyss to treat moderate-to-severe AD in adults & children (≥12yrs.) weighing 88 pounds (40kg). Lilly holds its exclusive rights outside the EU, while Almirall has licensed rights in the EU
The approval was supported by P-III (ADvocate 1 & 2) studies of Ebglyss alone and P-III (ADhere) study of…
Shots:
The US FDA has approved Tecentriq Hybreza (SC) to treat all IV indications, incl. lung, liver, skin & soft tissue cancers. Regulatory reviews across other regions are underway
The approval was supported by P-IB/III (IMscin001) study assessing Tecentriq Hybreza (SC) vs Tecentriq (IV) in locally advanced or metastatic NSCLC patients (n=371) failed on…
Shots:
PharmaShots has compiled a list of US FDA-approved drugs in the month of August 2024
The US FDA has approved a total of 7 new drugs including 4 new molecular entities and 3 biologics leading to the treatments for patients and advances in the healthcare industry
The major highlighted drug was Johnson & Johnson’s Rybrevant plus Lazcluze…
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 Sandoz’s Enzeevu for Treating Neovascular Age-Related…
Shots:
The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer
HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…
Shots:
The EC has granted approval to PiaSky (crovalimab) for treating PNH in adults & adolescents (≥12yrs., weight: ≥40kg) who are either treatment-experienced or treatment-naïve
Approval was based on P-III (COMMODORE 2) trial assessing PiaSky vs eculizumab in PNH patients not treated with C5 inhibitors plus results from another P-III trials, COMMODORE 1 (PNH patients…
Shots:
Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications
Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as…
Shots:
Following recommendations from the EMA’s CHMP & COMP, the EC has approved Akantior to treat AK among adults & adolescents (≥12yrs.)
Approval was based on the data from P-III (ODAK) study in AK patients (n=135), published in Ophthalmology, demonstrating that the disease cured in 84.8%, full vision restoration was found in 66.7% with…
Shots:
The EC has granted approval to Winrevair (45 & 60mg) combined with other PAH therapies to treat PAH, valid across whole EU as well as Iceland, Liechtenstein & Norway
Approval was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg, SC, Q3W;…
Shots:
Following the US FDA approval, the EC has approved Eurneffy (2mg) for type I allergic reactions (anaphylaxis) in adults & children (≥30kg). It will be available in Q4’24 through undisclosed pharmaceutical partner
The approval was supported by the results from a study, involving ~1200 administrations among >700 subjects, along with studies and peer-reviewed literature…

