Aemps publishes five new IPTs in October

Spanish Agency for Medicines and Health Products (Aemps) has published a new round of Therapeutic Positioning Inquiries (PTI) with five new drugs, one of which is a next-generation biologic. In particular, they are intended for the treatment of atopic dermatitis. diffuse large B-cell lymphoma (LBDCG), indolent systemic mastocytosis (ISM), neuronal ceroid lipofuscinosis type 2 (LCN2) and myasthenia gravis.

So this is the first batch this month published by the agency he runs. Maria Jesus Lamas. Although five new drugs have been announced that will begin reporting, and four drugs that will expand their indications.

In this sense, lebrikizumab (Ebgliss) for atopic dermatitis was given the green light in this round. This is a new generation biological drug intended to treat this disease. non-contagious inflammatory skin diseases, characterized by the presence of eczematous lesions, xerosis and intense itching. This is a chronic pathology that manifests itself in outbreaks of varying duration and intensity, as well as periods of remission, although in some cases symptoms may be constant.

As stated in this IPT, lebrikizumab is approved in the EU for the treatment of moderate to severe hypertension in adults and adolescents over 12 years of age with body weight not less than 40 kg who are candidates for systemic therapy. “It is available as an injection solution of 250 mg. pre-filled syringe and pre-filled pen. The recommended dose is 500 mg (two 250 mg injections) at weeks 0 and 2, then 250 mg subcutaneously every two weeks until week 16. Once clinical response is achieved, the recommended maintenance dose is 250 mg every four weeks”they detail.

The second drug that currently has an IPT is loncastuximab tesirine (Zinlonta) as monotherapy for the treatment of adult patients with diffuse large B-cell lymphoma (LBDCG) and high-grade B lymphoma (LBAG), relapsed or refractory after two or more lines of systemic treatment. In this sense, they specify that it is administered intravenously. through a 30-minute infusion. The recommended dose is 0.15 mg/kg every 21 days for the first two cycles. For subsequent cycles, a dose of 0.075 mg/kg every 21 days is recommended until disease progression or unacceptable toxicity. Unless contraindicated, patients should be premedicated with dexamethasone (4 mg orally or intravenously twice daily for 3 days, starting the day before Lonka administration) to reduce pyrrolobenzodiazepine (PBD)-associated toxicity. The dose of Lonka may be changed depending on hematological and non-hematological adverse reactionsas stated in the technical data sheet.

IPT for indolent systemic mastocytosis

On the other hand, Aemps also indicated that Avapritinib (Ayvakit) is also available for the treatment of adult patients with indolent systemic mastocytosis (MSI) with moderate to severe symptoms that are not adequately controlled by symptomatic treatment. “Mastocytoses constitute a group heterogeneous rare diseasescharacterized by clonal expansion and accumulation of mast cells (clonal mast cells, MCs) in various organs,” the document explains.

As for the recommended dose, it is 25 mg of avapritinib orally once a day with empty stomach (at least 1 hour before or 2 hours after meals, with a glass of water). This once-daily dose is also the maximum recommended dose and should not be exceeded in patients with MSI. Treatment for MSI should be continued until it occurs. disease progression (PE) or unacceptable toxicity.

Although there are also positive reviews of cerliponase alfa (Brineura) in the treatment neuronal lipofuscinosis ceroid type 2 (LCN2), also called tripeptidyl peptidase 1 (TPP1) deficiency. This is a group of hereditary neurodegenerative diseases clinically characterized by a decrease mental capacity, epilepsy and vision loss retinal degeneration and histologically intracellular accumulation of autofluorescent material, ceroid lipofuscin, in neuronal cells of the brain and retina.

“Cerliponase alfa should only be administered in a clinical setting and by a healthcare professional with appropriate training and knowledge of intracerebroventricular injection. It is administered by infusion into the cerebrospinal fluid (CSF) through a reservoir and catheter implanted during surgery (intracerebroventricular access device),” the IPT summarizes.

IPT for myasthenia gravis

Finally, Aemps has developed the IPT of rozanolikizumab (Ristiggo) as an adjunct to standard therapy to treat Generalized myasthenia in adult patients with positive antibodies against AChR or MuSK. It is a chronic autoimmune neuromuscular disease in which pathogenic autoantibodies such as immunoglobulin G (IgG) are produced that bind to acetylcholine receptors (AChRs) or functionally related molecules in the postsynaptic membrane of the neuromuscular junction.

“It comes in the form of an injection solution with 140 mg/ml rosanolikizumab. Treatment should be initiated and supervised by a specialized physician experienced in treating patients with neuromuscular or neuroinflammatory disorders. The recommended dose is 280–840 mg per week depending on body weight. Rosanolikizumab is used in cycles of treatment. The cycle consists of 1 dose per week for 6 weeks“, they conclude.