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      Evaluación positiva de medicamentos: abril, mayo y junio 2022 Translated title: Positive assessment of drugs: from April, May and June of 2022

      brief-report
      Author(s): , , ,
      Publication date (Print and electronic):
      Journal: Sanidad Militar
      Publisher: Ministerio de Defensa
      Keywords: Asciminib (Scemblix®), Budesonide (Kinpeygo®), Capmatinib (Travecta®), Efgartigimod Alfa (Vyvgart®), Eladocagene Exuparvovec (Upstaza®), Eptacog Beta Activated (Cevenfacta®), Birch Bark Extract (Fisulvez®), Lasmiditan (Rayvow®), Lenacapavir (Sunlenca®), Melphalan Flufenamide (Pepaxti®), Mosunetuzumab (Lunsumio®), Olipudase Alfa (Xenpozyme®), Lonafarnib (Zokinvy®), COVID-19 vaccine (inactivated, adjuvanted, adsorbed) (Valneva®), Valoctocogene Roxaparvovec (Roctavian®), Asciminib (Scemblix®), Budesonida (Kinpeygo®), Capmatinib (Travecta®), Efgartigimod Alfa (Vyvgart®), Eladocagene Exuparvovec (Upstaza®), Eptacog Beta Activado (Cevenfacta®), Extracto de corteza de abedul (Fisulvez®), Lasmiditan (Rayvow®), Lenacapavir (Sunlenca®), Melfalán Flufenamida (Pepaxti®), Mosunetuzumab (Lunsumio®), Olipudasa Alfa (Xenpozyme®), Lonafarnib (Zokinvy®), Vacuna frente a Covid-19 (inactivada, con adyuvante, adsorbida) (Valneva®), Valoctocogene Roxaparvovec (Roctavian®)

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          Abstract

          RESUMEN Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento hechos públicos de abril a junio 2022, y considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento.

          Translated abstract

          SUMMARY The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency made public from April to June of 2022, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product.

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          Most cited references23

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          Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial

          James Howard, Vera Bril, Tuan Vu … (2021)
          There is an unmet need for treatment options for generalised myasthenia gravis that are effective, targeted, well tolerated, and can be used in a broad population of patients. We aimed to assess the safety and efficacy of efgartigimod (ARGX-113), a human IgG1 antibody Fc fragment engineered to reduce pathogenic IgG autoantibody levels, in patients with generalised myasthenia gravis.
          Article 0 comments Cited 194 times – based on 0 reviews     Review now
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            Long-term efficacy and safety of eladocagene exuparvovec in patients with AADC deficiency

            Chun-Hwei Tai, Ni-Chung Lee, Yin-Hsiu Chien … (2021)
            Aromatic L-amino acid decarboxylase deficiency results in decreased neurotransmitter levels and severe motor dysfunction. Twenty-six patients without head control received bilateral intraputaminal infusions of a recombinant adeno-associated virus type 2 vector containing the human aromatic L-amino acid decarboxylase gene (eladocagene exuparvovec) and have completed 1-year evaluations. Rapid improvements in motor and cognitive function occurred within 12 months after gene therapy and were sustained during follow-up for >5 years. An increase in dopamine production was demonstrated by positron emission tomography and neurotransmitter analysis. Patient symptoms (mood, sweating, temperature, and oculogyric crises), patient growth, and patient caretaker quality of life improved. Although improvements were observed in all treated participants, younger age was associated with greater improvement. There were no treatment-associated brain injuries, and most adverse events were related to underlying disease. Post-surgery complications such as cerebrospinal fluid leakage were managed with standard of care. Most patients experienced mild to moderate dyskinesia that resolved in a few months. These observations suggest that eladocagene exuparvovec treatment for aromatic L-amino acid decarboxylase deficiency provides durable and meaningful benefits with a favorable safety profile.
            Article 0 comments Cited 47 times – based on 0 reviews     Review now
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              Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

              Messoud Ashina, Uwe Reuter, Timothy C. Smith … (2021)
              Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg (p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810
              Article 0 comments Cited 27 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (publisher-id): sm
                Title: Sanidad Militar
                Abbreviated Title: Sanid. Mil.
                Publisher: Ministerio de Defensa (Madrid, Madrid, Spain )
                ISSN (Print): 1887-8571
                Publication date (Print and electronic): September 2022
                Volume: 78
                Issue: 3
                Pages: 182-187
                Affiliations
                [2] Madrid orgnameHospital Central de la Defensa Gómez Ulla orgdiv1Servicio de Farmacia Hospitalaria España
                [4] Madrid orgnameHospital Central de la Defensa Gómez Ulla orgdiv1Servicio de Farmacología Clínica España
                [1] Madrid orgnameHospital Central de la Defensa Gómez Ulla orgdiv1Servicio de Farmacia Hospitalaria España
                [3] Madrid orgnameHospital Central de la Defensa Gómez Ulla orgdiv1Servicio de Farmacología Clínica España
                Article
                Publisher ID: S1887-85712022000300010 Publisher ID: S1887-8571(22)07800300010
                DOI: 10.4321/s1887-857120220003000010
                SO-VID: 1b40865b-a9d1-43fe-9f5e-2250c6a63de5
                License:

                http://creativecommons.org/licenses/by/4.0/

                History
                Date received : 22 August 2022
                Date accepted : 25 August 2022
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 23, Pages: 6
                Product

                SciELO Spain

                Categories
                Subject: Nota Técnica

                Keywords: Efgartigimod Alfa (Vyvgart®),Vacuna frente a Covid-19 (inactivada, con adyuvante, adsorbida) (Valneva®),Lonafarnib (Zokinvy®),Olipudasa Alfa (Xenpozyme®),Mosunetuzumab (Lunsumio®),Melfalán Flufenamida (Pepaxti®),Lenacapavir (Sunlenca®),Lasmiditan (Rayvow®),Extracto de corteza de abedul (Fisulvez®),Eptacog Beta Activado (Cevenfacta®),Eladocagene Exuparvovec (Upstaza®),Capmatinib (Travecta®),Budesonida (Kinpeygo®),Asciminib (Scemblix®),Valoctocogene Roxaparvovec (Roctavian®),COVID-19 vaccine (inactivated, adjuvanted, adsorbed) (Valneva®),Olipudase Alfa (Xenpozyme®),Melphalan Flufenamide (Pepaxti®),Birch Bark Extract (Fisulvez®),Eptacog Beta Activated (Cevenfacta®),Budesonide (Kinpeygo®)
                Data availability:
                Keywords: Efgartigimod Alfa (Vyvgart®), Vacuna frente a Covid-19 (inactivada, con adyuvante, adsorbida) (Valneva®), Lonafarnib (Zokinvy®), Olipudasa Alfa (Xenpozyme®), Mosunetuzumab (Lunsumio®), Melfalán Flufenamida (Pepaxti®), Lenacapavir (Sunlenca®), Lasmiditan (Rayvow®), Extracto de corteza de abedul (Fisulvez®), Eptacog Beta Activado (Cevenfacta®), Eladocagene Exuparvovec (Upstaza®), Capmatinib (Travecta®), Budesonida (Kinpeygo®), Asciminib (Scemblix®), Valoctocogene Roxaparvovec (Roctavian®), COVID-19 vaccine (inactivated, adjuvanted, adsorbed) (Valneva®), Olipudase Alfa (Xenpozyme®), Melphalan Flufenamide (Pepaxti®), Birch Bark Extract (Fisulvez®), Eptacog Beta Activated (Cevenfacta®), Budesonide (Kinpeygo®)

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