Lomitapid (1) – Lojuxta®
Hypercholesterolemia
Characteristics
| Start date | 15.12.2013 – Marketing authorisation: 31.07.2013 |
|---|---|
| Resolution | 05.06.2014 repealed |
| Limitation date | 15.06.2015 |
| INN | Lomitapid |
| Brand name | Lojuxta® |
| Pharm. company | Aegerion Pharmaceuticals GmbH |
| G-BA Procedure ID | D-093 |
| ATC code | C10AX12 Other lipid modifying agents (C10AX) |
| DDD | 40 mg O |
| Therapeutic area | Metabolic diseases Hypercholesterolemia |
| Reason for procedure |
Initial assessment
Repealed by: Lomitapid (2) (27.11.2015) |
| Regulatory status | Exceptional Circumstances |
| Therapeutic indication of the resolution |
|---|
|
Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with homozygous familial hypercholesterolaemia: patients in whom drug and dietary options for lipid lowering have been exhausted. | LDL apheresis, if necessary with concomitant drug lipid-lowering therapy |
| b) | Adult patients with homozygous familial hypercholesterolaemia: patients in whom drug and dietary options for lipid lowering have not been exhausted. | Maximum tolerated drug and dietary therapy for lipid lowering |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
a) Patients for whom pharmacological and dietary options for lowering lipid levels have been exhausted
- As the necessary proof has not been provided in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
b) Patients for whom pharmacological and dietary options for lowering lipids have not been exhausted
- As the necessary evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V)).
Courtesy translation only, please refer to the German original.
Associated procedures
| Lomitapid (2) | Lojuxta® | Aegerion Pharmaceuticals GmbH | Hypercholesterolemia | 60–69 | 100% additional benefit not proven | |
| Lomitapid (1) | Lojuxta® | Aegerion Pharmaceuticals GmbH | Hypercholesterolemia |
0
61–71 |
100% additional benefit not proven repealed |
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