The Regulatory Challenges for Drug Repurposing During the Covid-19 Pandemic: The Italian Experience

Gozzo, Lucia; Longo, Laura; Vitale, Daniela Cristina; Drago, Filippo

doi:10.3389/fphar.2020.588132

Cited by 14 publications

(14 citation statements)

References 12 publications

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“…Available at: https://ec.europa.eu/health/sites/health/files. Offlabel is not regulated at the European level, but specific national measures have been adopted (109,110). In general, this use is not reimbursable excluding selected cases defined by law.…”

Section: The Regulatory Perspective: Off-label Usementioning

confidence: 99%

Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue

et al. 2021

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Fertility preservation represents one important goal of cancer patients’ management due to the high impact on health and quality of life of survivors. The available preventive measures cannot be performed in all patients and are not feasible in all health-care facilities. Therefore, the pharmacological treatment with GnRHa has become a valuable non-invasive and well-tolerated alternative, especially in those who cannot access to cryopreservation options due to clinical and/or logistic issues. Supporting data demonstrate a significant advantage for the survivors who received GnRHa in the long-term maintenance of ovarian function and preservation of fertility. The prevention of the risk of ovarian failure with GnRHa is a typical off-label use, defined as the administration of a medicinal product not in accordance with the authorized product information. Italy has officially recognized the off-label use of GnRHa in adult women at risk of premature and permanent menopause following chemotherapy. However, fertility preservation still represents an unmet medical need in adolescents who cannot access to other treatment options.

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Section: The Regulatory Perspective: Off-label Usementioning

confidence: 99%

Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue

et al. 2021

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“…Currently, off-label use is not regulated in Europe, but some member states adopted specific national measures ( 115 , 117 ). For example, the France Recommandations Temporaires d’Utilisation (RTU) ( 118 ) and the Italian Law 648/1996 ( 119 , 120 ) ensure a nationwide access to off-label drugs according to criteria for appropriate use and monitoring defined in the light of clinical evidence (at least phase II trials for 648/96).…”

Section: The Regulatory Perspective: Off-label Usementioning

confidence: 99%

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

et al. 2021

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Despite the availability of a lot of effective disease-modifying drugs, multiple sclerosis (MS) (in particular the progressive forms) still represents an important unmet medical need, because of issues in terms of effectiveness, duration of response, safety, and patient compliance. An increasing body of evidence from randomized clinical trials and real-world data suggest that rituximab is a highly effective alternative in both relapsing and progressive MS, with a low discontinuation rate, related to a good benefit/risk profile, and a good compliance. To date, the use of rituximab in patients with multiple sclerosis is not in accordance with the authorized product information (off-label use). However, the use of this medicine is widespread in several countries, and in some cases, it is the most commonly used disease-modifying drug for MS subtypes. This use could be officially recognized by national regulatory authorities, according to specific procedures, to ensure equal access for patients to a safe and effective option.

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“…On October 6th the Italian Medicines Agency (AIFA) published a document with information useful to guide the prescription of corticosteroid in patients with Covid-19 (AIFA, 2020). However, the use has not been officially approved by the same Agency, so the treatment still falls within the scope of the off-label legislation, the so-called "Di Bella Law" (Gozzo et al, 2020;Di Bella, 2010), which allows the physicians to perform offlabel prescriptions in individual and exceptional cases, unless the local Health Director of the hospital formally authorize case by case the use. Anyway, the NHS does not cover the cost of the treatment.…”

Section: From European Approval To Patients' Accessmentioning

confidence: 99%

“…The only case in which an off-label use can be reimbursed in Italy is about drugs included in specific lists under the Law 648/1996(Law 648, 1996. In this context, during the emergency AIFA provisionally endorsed the use and reimbursement of some drugs, such as hydroxychloroquine/cloroquine, lopinavir/ritonavir, and darunavir/cobicistat, despite the non-applicability of the Law 648/1996, subsequently revoked due to the lack of data supporting a favorable risk-benefit profile (Gozzo et al 2020).…”

Section: From European Approval To Patients' Accessmentioning

confidence: 99%

Dexamethasone Treatment for Covid-19, a Curious Precedent Highlighting a Regulatory Gap

et al. 2020

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The Regulatory Challenges for Drug Repurposing During the Covid-19 Pandemic: The Italian Experience

Cited by 14 publications

References 12 publications

Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue

Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

Dexamethasone Treatment for Covid-19, a Curious Precedent Highlighting a Regulatory Gap

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