Skip to content Skip to footer
Subscribe Now
Novo-Nordisk
NEWS

Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors

Shots:The US FDA has approved label expansion of Alhemo (concizumab-mtci) to prevent or reduce the frequency of bleeding episodes in pts (≥12yrs.) with HA/HB without inhibitorsApproval was based on P-III (Explorer8) trial assessing Alhemo (n=42, 1mg/kg followed by 0.2mg/kg QD) vs no prophylaxis (n=21) in 156 males with HA/HB, where median duration of…
August 1, 2025

Read more

Novo-Nordisk
NEWS

Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors 

Shots:   The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A…
December 20, 2024

Read more

EMA Marketing Authorization of New Drugs in October 2024
INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2024

Shots:   The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis PharmaShots has…
November 21, 2024

Read more

Novo Nordisk
NEWS

Novo Nordisk’s Alhemo Gains the CHMP’s Positive Opinion as a Prophylatic Treatment of Hemophilia A or B

      Shots:   The CHMP has recommended Alhemo (QD, SC) as a prophylactic treatment of hemophilia A/B with inhibitors in patients (≥12yrs.), with the EC’s decision anticipated within ~2mos.   The opinion was based on the P-III (explorer7) study assessing the efficacy & safety of Alhemo to treat haemophilia A or B with inhibitors. Alhemo will be available…
October 18, 2024

Read more