Aemps is working on 5 IPTs and 4 new indications.
Appearance of Aemps.
Spanish Agency for Medicines and Health Products (Aemps) is already in practice with several reports of positioning therapy (IPT). In particular, for five drugs that received a positive conclusion centrally at a meeting of the Committee on Medicinal Products for Human Use (CHMP) of the Russian Ministry of Health. European Medicines Agency (EMA, English abbreviation), held in June this year.
“As for new drugs, The process of preparing for IPT will begin the moment Aemps receives from marketing authorization holder (TAC)notification of the intention to sell these medicines in Spain and application of national code“, they note from Aemps.
What new IPTs will start? According to the agency, they will report on Balversa (erdafitinib) from Janssen-Cilag International as a monotherapy, which is indicated for the treatment of adult patients with urothelial carcinoma (UC) unresectable or metastatic carriers of specific FGFR3 genetic alterations who have previously received at least one line of treatment with a PD-1 or PD-L1 inhibitor in the context of unresectable or metastatic treatment.
In addition, they will create IPT Eurneffy (adrenaline) from Ars Pharmaceuticals Irl Limited, indicated as an emergency treatment. allergic reactions (anaphylaxis) due to insect bites, food, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis. Treatment is indicated for adults and children weighing ≥30 kg; and Ordspono (odronextamab) from Regeneron Ireland Designated Activity Company as a monotherapy indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (LF R/R) after two or more lines of systemic treatment.
Medicines approved by the EMA
In this direction, the agency, led by Maria Jesús Lamas, will also study Piasci (crovalimab) from Roche in monotherapy, which is indicated for the treatment of adults and children aged 12 years and older with a weight equal to or greater than 40 kg. paroxysmal nocturnal hemoglobinuria (CRF); and Vinrevare (sotatercept) from Merck in combination with other drugs to treat pulmonary arterial hypertension (HAP), indicated for the treatment of PAH in adult patients of WHO functional class (FC) II–III, to improve exercise tolerance.
As for new indications or modifications, they will be carried out for four drugs: Imfinzi (durvalumab) for a new indication for endometrial cancer; Lynparza (olaparib) in expanding indications for endometrial cancer; Tepkinli (epcoritamab) as an expansion of indications for the treatment of adult patients with follicular lymphoma (LF) relapsed or refractory after two or more lines of systemic treatment; and Vabismo (faricimab) as an expanded indication for visual impairment due to secondary macular edema to retinal vein occlusion.
To begin this process, the Agency asks TAC to contact ipt@aemps.es. indicating its intention or not to commercialize in Spain new medicines that have received a positive conclusion in a centralized manner; In this case, they must request the national code through the RAEFAR II application and provide a TAC contact person.
“As for new indications or modifications of thesethe IPT preparation process will begin without the need to send these TAC messages,” they conclude.
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