Update for January 6, 2021
The FDA approved ansuvimab (Ebanga, Ridgeback Biotherapeutics), on 12/21/2020, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children.
The FDA approved vibegron (Gemtesa, Urovant Sciences), on 12/23/2020, for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
The FDA rejected arbaclofen due to inadequate justification for the statistical analysis of a primary endpoint (TNmAS-MAL scores at Day 84) in a pivotal trial. The FDA has recommended a new efficacy study be performed.
In November 2020, Voyager paused the RESTORE-1 trial when the data safety and monitoring board (DSMB) requested time to analyze MRI imaging abnormalities. The FDA placed a hold on the RESTORE-1 trial in December 2020 due to these abnormalities.
Chi-Med initiated a rolling NDA in December 2020 for surufatinib as a treatment of advanced neuroendocrine tumors and plans to complete the submission in the first half of 2021.
The EMA approved ViiV Healthcare’s cabotegravir injection in combination with rilpivirine for the treatment of HIV-1 infection in adults who are virologically suppressed.
Cara submitted an NDA for difelikefalin, for the treatment of moderate-to-severe pruritus in hemodialysis patients, in December 2020.
The FDA designated Immunicum’s Ilixadencel an Orphan Drug for the treatment of hepatocellular carcinoma.
Announced Research Updates
Amgen and AstraZeneca announced that in the 48-week, 150 patient, Phase III SOURCE trial, treatment with tezepelumab did not reduce daily oral corticosteroids (OCS), without loss of asthma control, compared to placebo in patients with severe asthma who require continuous treatment with inhaled corticosteroids plus long-acting beta2-agonists, and chronic treatment with maintenance OCS.
BioMarin announced one-year data from a 119 patient extension of a 121 patient, Phase III trial, where patients treated with vosoritide achieved an increase in height of 1.79 cm more than placebo in children with achondroplasia.
ChemoCentryx and VFMCRP announced that in the 26-week, 88 patient, Phase II ACCOLADE trial, treatment with avacopan improved the C3G Histologic Index for Disease Activity by 2% compared to a 38% worsening with placebo in patients with C3 Glomerulopathy.
Supernus announced that in a 6-week, 374 patient, Phase III trial, viloxazine decreased the ADHD Investigator Symptom Rating Scale (AISRS) score by 15.5 points compared to an 11.7 point decrease with placebo in adults (age 18 to 65) with attention deficit hyperactivity disorder.
Aprea Therapeutics announced that in a 154 patient, Phase III trial, treatment with eprenetapopt plus azacitidine did not improve the complete remission rate compared to azacitidine alone in patients with TP53 mutant myelodysplastic syndromes.
Published Research Updates
In an 11.9-month interim analysis of a 412 patient, Phase III, open-label trial, carboplatin/pemetrexed/camrelizumab followed by pemetrexed/camrelizumab maintenance resulted in progression free survival (PFS) of 11.3 months compared to 8.3 months with carboplatin/pemetrexed followed by pemetrexed alone in Chinese patients with in non-small cell lung cancer.
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