- Approval Id
- 24b831b7eb04b2e6
- Drug Approval Emc Name
- Nintedanib Advanz Pharma 150 mg soft capsules
- Drug Name
- Nintedanib Advanz Pharma 150 mg soft capsules
- Company Address
- Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK
- Company Website
- https://medicalinformation.advanzpharma.com/
- Company Telephone
- +44 (0)208 588 9131
- Company Medical Info Direct Line
- +44 (0)208 588 9131
- Company Medical Info Email
- [email protected]
- Company Customer Care Direct Line
- +44 (0)208 588 9273
- Atc Code
- L01EX09
- Legal Category
- Prescription only medicine
- Authorisation Holder
- 7. Marketing authorisation holder Advanz Pharma Limited Unit 17, Northwood House Northwood Cresent County Dublin Dublin 9, D09V504 Ireland
- Authorisation Number
- 8. Marketing authorisation number(s) PL 56734/0030
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation Date of first authorisation: 07 November 2025 Date of latest renewal: NA
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Advanz Pharma Limited Unit 17, Northwood House Northwood Cresent County Dublin Dublin 9, D09V504 Ireland
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 56734/0030
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation Date of first authorisation: 07 November 2025 Date of latest renewal: NA
- Instruction Composition
- 2. Qualitative and quantitative composition Nintedanib Advanz Pharma 150 mg soft capsules Each soft capsule contains nintedanib esilate equivalent to 150 mg nintedanib For the full list of excipients, see section 6.1
- Instruction Dosage Form
- 3. Pharmaceutical form Soft capsule (capsule) Nintedanib Advanz Pharma 150 mg soft capsules Brown, opaque, oblong capsule containing yellow viscous suspension, imprinted with “NT 150” in black ink and approximately 17 mm in length.
- Instruction Clinical Particulars
- 4. Clinical particulars 4.1 Therapeutic indications Nintedanib Advanz Pharma is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Advanz Pharma is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01EX09 Mechanism of action Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1‑3, and VEGFR 1‑3. In addition, nintedanib inhibits Lck (lymphocyte-specific tyrosine-protein kinase), Lyn (tyrosine-protein kinase lyn), Src (proto-oncogene tyrosine-protein kinase src), and CSF1R (colony stimulating factor 1 receptor) kinases. Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases and blocks the intracellular signalling cascades, which have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodelling in interstitial lung diseases. Pharmacodynamic effects In in vitro studies using human cells nintedanib has been shown to inhibit processes assumed to be involved in the initiation of the fibrotic pathogenesis, the release of pro-fibrotic mediators from peripheral blood monocytic cells and macrophage polarisation to alternatively activated macrophages. Nintedanib has been demonstrated to inhibit fundamental processes in organ fibrosis, proliferation and migration of fibroblasts and transformation to the active myofibroblast phenotype and secretion of extracellular matrix. In animal studies in multiple models of IPF, SSc/SSc‑ILD, rheumatoid arthritis-associated‑(RA‑) ILD and other organ fibrosis, nintedanib has shown anti-inflammatory effects and anti-fibrotic effects in the lung, skin, heart, kidney, and liver. Nintedanib also exerted vascular activity. It reduced dermal microvascular endothelial cell apoptosis and attenuated pulmonary vascular remodelling by reducing the proliferation of vascular smooth muscle cells, the thickness of pulmonary vessel walls and percentage of occluded pulmonary vessels. Clinical efficacy and safety Idiopathic pulmonary fibrosis (IPF) The clinical efficacy of nintedanib has been studied in patients with IPF in two phase III, randomised, double-blind, placebo-controlled studies with identical design (INPULSIS‑1 (1199.32) and INPULSIS‑2 (1199.34)). Patients with FVC baseline <50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) <30% predicted at baseline were excluded from the trials. Patients were randomized in a 3:2 ratio to treatment with nintedanib 150 mg or placebo twice daily for 52 weeks. The primary endpoint was the annual rate of decline in forced vital capacity (FVC). The key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score at 52 weeks and time to first acute IPF exacerbation. Annual rate of decline in FVC The annual rate of decline of FVC (in mL) was significantly reduced in patients receiving nintedanib compared to patients receiving placebo. The treatment effect was consistent in both trials. See Table 3 for individual and pooled study results. Table 3: Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set INPULSIS‑1 INPULSIS‑2 INPULSIS‑1 and INPULSIS‑2 pooled Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Number of analysed patients 204 309 219 329 423 638 Rate1 (SE) of decline over 52 weeks −239.9 (18.71) −114.7 (15.33) −207.3 (19.31) −113.6 (15.73) −223.5 (13.45) −113.6 (10.98) Comparison vs placebo Difference1 125.3 93.7 109.9 95% CI (77.7, 172.8) (44.8, 142.7) (75.9, 144.0) p-value <0.0001 0.0002 <0.0001 1 Estimated based on a random coefficient regression model. CI: confidence interval In a sensitivity analysis which assumed that in patients with missing data at week 52 the FVC decline after the last observed value would be the same as in all placebo patients, the adjusted difference in the annual rate of decline between nintedanib and placebo was 113.9 mL/year (95% CI 69.2, 158.5) in INPULSIS‑1 and 83.3 mL/year (95% CI 37.6, 129.0) in INPULSIS‑2. See Figure 1 for the evolution of change from baseline over time in both treatment groups, based on the pooled analysis of studies INPULSIS‑1 and INPULSIS‑2. Figure 1: Mean (SEM) observed FVC change from baseline (mL) over time, studies INPULSIS-1 and INPULSIS-2 pooled bid=twice daily FVC responder analysis In both INPULSIS trials, the proportion of FVC responders, defined as patients with an absolute decline in FVC % predicted no greater than 5% (a threshold indicative of the increasing risk of mortality in IPF), was significantly higher in the nintedanib group as compared to placebo. Similar results were observed in analyses using a conservative threshold of 10%. See Table 4 for individual and pooled study results. Table 4: Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set INPULSIS‑1 INPULSIS‑2 INPULSIS‑1 and INPULSIS‑2 pooled Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Number of analysed patients 204 309 219 329 423 638 5% threshold Number (%) of FVC responders1 78 (38.2) 163 (52.8) 86 (39.3) 175 (53.2) 164 (38.8) 338 (53.0) Comparison vs placebo Odds ratio 1.85 1.79 1.84 95% CI (1.28, 2.66) (1.26, 2.55) (1.43, 2.36) p-value2 0.0010 0.0011 <0.0001 10% threshold Number (%) of FVC responders1 116 (5
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Capsule content Triglycerides, medium-chain Hard fat Polyglyceryl-3 dioleate Capsule shell Gelatin Glycerol Titanium dioxide (E 171) Iron oxide red (E 172) Iron oxide yellow (E 172) Water, purified Printing ink Shellac Black iron oxide (E172) Propylene glycol (E 1520) 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Nintedanib Advanz Pharma 150 mg soft capsules 60 x 1 soft capsules in OPA/Al/PVC‑Aluminum perforated unit dose blisters. 6.6 Special precautions for disposal and other handling In the event of coming in contact with the content of the capsule, hands should be washed off immediately with plenty of water (see section 4.2). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Nintedanib Advanz Pharma 150 mg soft capsules Each soft capsule contains nintedanib esilate equivalent to 150 mg nintedanib For the full list of excipients, see section 6.1
## Pharmaceutical Form
3. Pharmaceutical form Soft capsule (capsule) Nintedanib Advanz Pharma 150 mg soft capsules Brown, opaque, oblong capsule containing yellow viscous suspension, imprinted with “NT 150” in black ink and approximately 17 mm in length.
## Clinical Particulars
4. Clinical particulars 4.1 Therapeutic indications Nintedanib Advanz Pharma is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Advanz Pharma is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01EX09 Mechanism of action Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1‑3, and VEGFR 1‑3. In addition, nintedanib inhibits Lck (lymphocyte-specific tyrosine-protein kinase), Lyn (tyrosine-protein kinase lyn), Src (proto-oncogene tyrosine-protein kinase src), and CSF1R (colony stimulating factor 1 receptor) kinases. Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases and blocks the intracellular signalling cascades, which have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodelling in interstitial lung diseases. Pharmacodynamic effects In in vitro studies using human cells nintedanib has been shown to inhibit processes assumed to be involved in the initiation of the fibrotic pathogenesis, the release of pro-fibrotic mediators from peripheral blood monocytic cells and macrophage polarisation to alternatively activated macrophages. Nintedanib has been demonstrated to inhibit fundamental processes in organ fibrosis, proliferation and migration of fibroblasts and transformation to the active myofibroblast phenotype and secretion of extracellular matrix. In animal studies in multiple models of IPF, SSc/SSc‑ILD, rheumatoid arthritis-associated‑(RA‑) ILD and other organ fibrosis, nintedanib has shown anti-inflammatory effects and anti-fibrotic effects in the lung, skin, heart, kidney, and liver. Nintedanib also exerted vascular activity. It reduced dermal microvascular endothelial cell apoptosis and attenuated pulmonary vascular remodelling by reducing the proliferation of vascular smooth muscle cells, the thickness of pulmonary vessel walls and percentage of occluded pulmonary vessels. Clinical efficacy and safety Idiopathic pulmonary fibrosis (IPF) The clinical efficacy of nintedanib has been studied in patients with IPF in two phase III, randomised, double-blind, placebo-controlled studies with identical design (INPULSIS‑1 (1199.32) and INPULSIS‑2 (1199.34)). Patients with FVC baseline <50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) <30% predicted at baseline were excluded from the trials. Patients were randomized in a 3:2 ratio to treatment with nintedanib 150 mg or placebo twice daily for 52 weeks. The primary endpoint was the annual rate of decline in forced vital capacity (FVC). The key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score at 52 weeks and time to first acute IPF exacerbation. Annual rate of decline in FVC The annual rate of decline of FVC (in mL) was significantly reduced in patients receiving nintedanib compared to patients receiving placebo. The treatment effect was consistent in both trials. See Table 3 for individual and pooled study results. Table 3: Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set INPULSIS‑1 INPULSIS‑2 INPULSIS‑1 and INPULSIS‑2 pooled Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Number of analysed patients 204 309 219 329 423 638 Rate1 (SE) of decline over 52 weeks −239.9 (18.71) −114.7 (15.33) −207.3 (19.31) −113.6 (15.73) −223.5 (13.45) −113.6 (10.98) Comparison vs placebo Difference1 125.3 93.7 109.9 95% CI (77.7, 172.8) (44.8, 142.7) (75.9, 144.0) p-value <0.0001 0.0002 <0.0001 1 Estimated based on a random coefficient regression model. CI: confidence interval In a sensitivity analysis which assumed that in patients with missing data at week 52 the FVC decline after the last observed value would be the same as in all placebo patients, the adjusted difference in the annual rate of decline between nintedanib and placebo was 113.9 mL/year (95% CI 69.2, 158.5) in INPULSIS‑1 and 83.3 mL/year (95% CI 37.6, 129.0) in INPULSIS‑2. See Figure 1 for the evolution of change from baseline over time in both treatment groups, based on the pooled analysis of studies INPULSIS‑1 and INPULSIS‑2. Figure 1: Mean (SEM) observed FVC change from baseline (mL) over time, studies INPULSIS-1 and INPULSIS-2 pooled bid=twice daily FVC responder analysis In both INPULSIS trials, the proportion of FVC responders, defined as patients with an absolute decline in FVC % predicted no greater than 5% (a threshold indicative of the increasing risk of mortality in IPF), was significantly higher in the nintedanib group as compared to placebo. Similar results were observed in analyses using a conservative threshold of 10%. See Table 4 for individual and pooled study results. Table 4: Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set INPULSIS‑1 INPULSIS‑2 INPULSIS‑1 and INPULSIS‑2 pooled Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Placebo Nintedanib 150 mg twice daily Number of analysed patients 204 309 219 329 423 638 5% threshold Number (%) of FVC responders1 78 (38.2) 163 (52.8) 86 (39.3) 175 (53.2) 164 (38.8) 338 (53.0) Comparison vs placebo Odds ratio 1.85 1.79 1.84 95% CI (1.28, 2.66) (1.26, 2.55) (1.43, 2.36) p-value2 0.0010 0.0011 <0.0001 10% threshold Number (%) of FVC responders1 116 (5
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Capsule content Triglycerides, medium-chain Hard fat Polyglyceryl-3 dioleate Capsule shell Gelatin Glycerol Titanium dioxide (E 171) Iron oxide red (E 172) Iron oxide yellow (E 172) Water, purified Printing ink Shellac Black iron oxide (E172) Propylene glycol (E 1520) 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Nintedanib Advanz Pharma 150 mg soft capsules 60 x 1 soft capsules in OPA/Al/PVC‑Aluminum perforated unit dose blisters. 6.6 Special precautions for disposal and other handling In the event of coming in contact with the content of the capsule, hands should be washed off immediately with plenty of water (see section 4.2). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Company Detail Path
- /organization/amdipharm-limited
