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MERCK
NEWS

Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH) 

Shots:  The CHMP has granted positive opinion to Winrevair combined with other therapies to treat PAH. EC’s decision is anticipated in Q3’24, applicable across EU, Iceland, Liechtenstein & Norway  The opinion was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg; n=163) or PBO (n=160) + stable background…
June 28, 2024

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Regeneron
NEWS

Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

Shots:  The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos.  The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates…
June 28, 2024

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Johnson& Johnson
NEWS

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC) 

Shots:  The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor  The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs…
June 28, 2024

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New Drug Designations - May 2024
INSIGHTS+

New Drug Designations – May 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 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
June 25, 2024

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Astrazeneca
NEWS

AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer 

      Shots:  The CHMP’s positive opinion of Tagrisso + pemetrexed & Pt-based CT as a 1L treatment of locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC with exon 19 deletions or exon 21 (L858R) mutations was based on P-III (FLAURA2) study  The P-III (FLAURA2) study assessed Tagrisso (80mg, oral, QD) + CT [pemetrexed…
June 3, 2024

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Takeda
NEWS

Takeda’s ADAMTS13 Receives the CHMP’s Positive Opinion for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 

Shots:  The CHMP has granted a positive opinion to ADAMTS13 (rADAMTS13) for treating ADAMTS13 deficiency in cTTP children and adults   The positive opinion was based on the P-III study assessing the efficacy, PK, safety, and tolerability for the same. Data was published in The New England Journal of Medicine in May 2024  rADAMTS13 is a…
May 31, 2024

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NEWS

Mirum Pharmaceuticals’ Livmarli (maralixibat) Receives the CHMP’s Positive Opinion for Progressive Familial Intrahepatic Cholestasis (PFIC) 

   Shots:  The CHMP has granted positive opinion to Livmarli (oral solution) for PFIC patients (age: ≥3mos.) along with COMP for maintaining ODD. EC’s decision is anticipated in Q3’24   The opinions were supported by the P-III (MARCH) trial involving 93 patients with PFIC types (PFIC1, PFIC2, PFIC3, PFIC4, PFIC6 & unidentified mutational status), showing decreased…
May 31, 2024

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Regeneron & Sanofi
NEWS

Sanofi & Regeneron’s Dupixent Receives the CHMP’s Positive Opinion for Treating Chronic Obstructive Pulmonary Disease (COPD) 

Shots:   The CHMP’s positive opinion of Dupixent as an add-on maintenance therapy for uncontrolled COPD patients with type 2 inflammation was based on P-II (BOREAS & NOTUS) studies assessing its safety & efficacy for the same  Studies met the 1EP depicting a 34% reduction in annualized moderate or severe acute COPD exacerbations, sustained lung function…
May 31, 2024

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