Publication date: October 17, 2024
Category: Medicines for humans
Link: IPT, 13/2024
- The therapeutic positioning reports prepared will be consistent with both new drugs and new indications or modifications that have received committee approval.
- In the case of new drugs, the Agency will begin the process of preparing the IPT the moment it receives from the laboratory a communication of the intention to market them in Spain and a request for a national code.
The Spanish Agency for Medicines and Health Products (AEMPS) is about to start working on therapeutic positioning reports (IPT) for medicinal products that have received a positive opinion through a centralized procedure at the meeting of the Committee for Medicinal Products for Human Use (CHMP). , abbreviation in English) of the European Medicines Agency (EMA), held in July 2024. These IPTs apply to both new drugs and new indications or modifications that have received committee approval and are described below.
In the case of new medicines, the IPT preparation process will begin the moment AEMPS receives from the marketing authorization holder (TAC) a communication of intent to market these medicines in Spain and an application for national registration. code. To do this, the Agency requests TAC to contact ipt@aemps.es indicating the following:
- Their intention or not to sell new drugs in Spain that have received a positive conclusion as a result of a centralized procedure.
- In this case, they must request the national code through the RAEFAR II application, as outlined in this guide.
- If AEMPS does not receive marketing confirmation and therefore the MA Holder does not request a national code for new medicinal products, preparation of the relevant IPT will not begin.
- TAS contact person.
For new indications or modifications, the IPT preparation process will begin without the TAC having to submit these messages to AEMPS.
In the event of revocation of the marketing authorization, change in ownership of the medicinal product or intention to sell it, information must be sent to the email address provided above.
The Agency reminds that the most up-to-date information on the financing situation of those PIPs that contain it should be found in the Information Retrieval System on the Financing Situation of Medicines (BIFIMED).
New drugs
| Medicine | Description |
|---|---|
| Anzupgo (delgocitinib) | Anzupgo from LEO Pharma A/S: Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or unsuitable. |
| Ikirvo (elafibranor) | Ikirvo from Ipsen Pharma: Ikirvo is indicated for the treatment of primary biliary cholangitis (PBC) 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. |
| Kayfanda (odevixibat) | Kaifanda from Ipsen Pharma: Kaifanda is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALS) from 6 months of age.
|
| Loctorzy (torapalimab) | Loctorzy from TMC Pharma (EU) Limited: Loctorzy in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with recurrent nasopharyngeal carcinoma that is refractory to surgery or radiotherapy or is metastatic.
Loctorzy in combination with cisplatin and paclitaxel is indicated for the first-line treatment of adult patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
|
| Vevisier (cyclosporine) | Vevizye from Novaliq GmbH: Treatment of moderate to severe xerophthalmia (keratoconjunctivitis sicca or dry eye) in adult patients whose condition has not improved despite treatment with artificial tears |
| Viloy (zolbetuximab) | Vyloy from Astellas Pharma Europe BV: Vyloy in combination with platinum-based chemotherapy and a fluoropyrimidine is indicated for the first-line treatment of adult patients with unresectable or metastatic locally advanced HER2-negative adenocarcinoma of the stomach or gastroesophageal junction (GEJ), whose tumors are Claudina positive ( CLDN) 18.2 |
New indications/modifications of indications
| Medicine | Description |
|---|---|
| Braftovi (encorafenib)/ Mektovi (binimetinib) | Modification of indication.
Non-small cell lung cancer (NSCLC)
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with the BRAF V600E mutation.
|
| Keytruda (pembrolizumab) | New indication.
Keytruda in combination with enfortumab vedotin is indicated for first-line treatment of unresectable or metastatic urothelial cancer in adults.
|
| Padtsev (enfortumab vedotin) | Display extension.
Padcev in combination with pembrolizumab is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma who are candidates for platinum-based chemotherapy.
Padtsev is indicated only 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 inhibitor or programmed death ligand 1 inhibitor.
|
| Rybrevant (amivantamab) | Display extension.
Rybrevant is shown:
in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior treatments, including EGFR tyrosine kinase inhibitor (TKI).
|
| Slenito (melatonin) | Modification of indication.
Slenito is indicated for the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder (ASD). I Smith-Magenis syndrome, neurogenetic disorders with aberrant daytime melatonin secretion and/or night awakeningsin which sleep hygiene measures were found to be insufficient.
|
| Spevigo (espesolimab) | Modification of indication.
150 mg solution for injection in a pre-filled syringe.
Spevigo is indicated for the maintenance treatment of generalized pustular psoriasis (GPP) in adults and adolescents over 12 years of age.
450 mg concentrate for solution preparation
Spevigo is indicated for the treatment of outbreaks in adult patients with from Generalized pustular psoriasis (GPP) in adults and adolescents over 12 years of age as monotherapy.
|
| Tecentriq (atezolizumab) | Modification of indication.
advanced NSCLC Metastatic
Tecentriq monotherapy is indicated as first-line therapy in adult patients with advanced NSCLC who are not eligible for platinum-based therapy.
|