Aemps begins work on PTI of six new drugs

Spanish Agency for Medicines and Health Products (Aemps) was launched with several Internal Positioning Therapy (IPT) reports. At the same time, there are 6 drugs that received a positive conclusion centrally at the meeting Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), held in July.

In fact, these IPTs correspond to both new drugs and new indications or modifications of which received committee approval. As Aemps points out, for new drugs, the IPT process will begin the moment the agency receives the TAC from the marketing authorization holder. notice of intent to sell these drugs in Spain and request the national code.

Among six drugs with which this report will begin are: Anzupgo ((delgocitinib) from LEO Pharma A/S, which is indicated for the treatment chronic hand eczema (MCE) moderate to severe in adults for whom topical corticosteroids are inadequate or inappropriate; Ikirvo (elafibranor) from Ipsen Pharma, intended for the treatment primary biliary cholangitis (CBP) in combination with ursodeoxycholic acid (UDCA) in adults who do not respond adequately to UDCA, or as monotherapy in patients who are intolerant to UDCA; and Kaifanda (odevixibat) from Ipsen Pharma, which is indicated for the treatment cholestatic itching in patients with Alagille syndrome (ALG) from 6 months of age.

In the same direction, the organization led by Maria Jesús Lamas will also work on Loctorzy (torapalimab) from TMC Pharma (EU) Limited in combination with cisplatin and gemcitabine, which is indicated for the first-line treatment of adult patients with recurrent nasopharyngeal cancernot amenable to surgery or radiation therapy, or metastatic; Vevisier (cyclosporine) from Novaliq GmbH for the treatment xerophthalmia (keratoconjunctivitis sicca or dry eye) moderate to severe in adult patients, the condition has not improved despite treatment with artificial tears; and Vyloy (zolbetuximab) from Astellas Pharma Europe BV in combination with platinum-based chemotherapy and fluoropyrimidine is indicated for the first-line treatment of adult patients with gastric adenocarcinoma or HER2-negative locally advanced unresectable or metastatic gastroesophageal junction (GEJ) tumors whose tumors are claudin-positive (CLDN).

New indications or modifications of the drug

On the other hand, Aemps also noted that they are going to do their best. seven new indications or modifications indications for the drug. The changes will affect: encorafenib in combination with binimetinib, which is indicated for the treatment of adult patients with advanced non-small cell lung cancer with the BRAF V600E mutation; Keytruda (pembrolizumab) adds new indication for first-line cancer therapy unresectable or metastatic urothelium in adults; expansion of the indications for Padtsev (enfortumab vedotin) in combination with pembrolizumab, which is indicated for first-line treatment in adult patients with inoperable urothelial cancer or metastatic, which are candidates for platinum-based chemotherapy.

In addition, Padtsev’s indications as monotherapy have been expanded and indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-based chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor; as well as indications for the use of Rybrevant, which is indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior treatment, including an EGFR tyrosine kinase inhibitor (TKI).

Finally, Slenyto is modified and becomes: specified for treatment of insomnia in children and adolescents from 2 to 18 years with autism spectrum disorders (ASD) and/or neurogenetic disorders with aberrant 24-hour melatonin secretion and/or night awakenings in which sleep hygiene measures were insufficient. There are also modifications of Spevigo, which is indicated for maintenance treatment generalized pustular psoriasis (PPG) in adults and adolescents over 12 years of age. Finally, Tecentriq is modified as monotherapy, which is indicated as first-line treatment adult patients with advanced NSCLC who are not eligible for platinum-based therapy.