dm+d
Unassigned
New Medicines
Saphnelo
as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapyInformation
Saphnelo
New molecular entity
AstraZeneca
MedImmune
Development and Regulatory status
Approved (Licensed)
Approved (Licensed)
Launched
Apr 22
Availability plans in England currently uncertain after NICE suspended its appraisal of anifrolumab because the company will not be making an evidence submission at this time [24].
Mar 22
Saphnelo is approved by the MHRA as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy [23]
Feb 22
Approved in the EU [22].
Dec 21
Recommended for EU approval by CHMP “as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.” Saphnelo will be available as a 300 mg concentrate for solution for infusion [21].
Aug 21
Launched in the US [20]
Aug 21
Approved in US [19].
Dec 20
Has also been filed in the US [16].
Nov 20
Regulatory decisions from the EMA and FDA are expected H2 2021 [18].
Nov 20
Filed in EU via centralised procedure [15].
Dec 19
EU and US filing expected for H2 2020. Fast Track Designation in US [13].
May 19
EU & US filings planned for 2020 [10].
Dec 17
Still on track for filing in 2019 according to AZ pipeline updated 9/11/17 [5]
Dec 16
EU &US filings still planned for 2019 [4]
Nov 15
US FDA recently assigned anifrolumab Fast Track designation [1].
Nov 15
A PI subcutaneous administration study is anticipated to begin in H2 2015 [1].
Sep 15
EU &US filings planned for 2019 [3].
Jul 15
PIII programme including the TULIP study begins [1].
Category
First-in-class fully human monoclonal antibody that binds to subunit 1 of the Type I IFN receptor, inhibiting the activity of all Type I IFNs including IFN-α, IFN-β and IFN-ω.
The UK prevalence of SLE is 25-28 per 100,000 population; over 90% develop arthralgia and myalgia.
as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy
Intravenous
Further information
Yes
Trial or other data
Mar 21
PII 3yr extension study (NCT01753193, n=218) found the rate and pattern of adverse effects were consistent with those reported at 1yr and few discontinued owing to adverse effects. Clinical improvements at 1yr were reported to be sustained at 3yrs [17].
Dec 19
PIII TULIP SLE2 (NCT02446899; n=362) is published in the NEJM; it found monthly administration of anifrolumab (300mg IV), a monoclonal antibody to type I interferon receptor subunit 1, resulted in higher response rate at week 52 than placebo (47.8 vs. 31.5%; p=0.001), in contrast to previous trial with different primary end point [14].
Nov 19
Outcome data from PIII TULIP 2 trial (n=365) available in which pts received either i.v. anifrolumab 9300mg) or placebo every month. The primary endpoint (as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment [BICLA] composite measure) at week 52 was acheived by 47.8% of pts receiving anifrolumab vs. 31.5% on placebo (reported as statistically significant). In addition, 51.5% of anifrolumab pts on oral steroids (OCS) showed a sustained reduction in OCS use vs. 30.2% with placebo and 49% on anifrolumab showed improved skin symptoms at week 12 vs. 25% on placebo.[12]
Aug 19
AstraZeneca announce PIII TULIP 2 trial meets primary endpoint of statistically-significant and clinically-meaningful reduction in disease activity measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52 [11].
Aug 18
Phase III trial results from the TULIP 1 study in adult patients with moderate-to-severe systemic lupus erythematosus (SLE) found that the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months was not met [8].
Feb 18
Results expected from TULIP SLE2 in H2 19 [9].
Dec 17
Data expected H2 18 from TULIP SLE1 (NCT02446912) and TULIP SLE2 (NCT02446899) [7].
Dec 17
NCT02547922 due to complete May 2019 [6]
Nov 15
PIII TULIP-LN1 (NCT02547922) will recruit 150 pts from 71 sites in the US, EU (including UK) and other countries worldwide. Primary outcome data collection should complete Apr 18 [2].
Nov 15
The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) programme includes two PIII clinical trials that will evaluate the efficacy and safety of anifrolumab versus placebo in patients with moderately to severely active, autoantibody-positive SLE, while receiving standard of care treatment. The programme will assess the effect of anifrolumab in reducing disease activity (as measured by the SRI), decreasing use of OCS, improving skin manifestations (as measured by CLASI) and reducing flares [1].
Nov 15
AstraZeneca & Medimmune announce that a PII trial met its primary endpoint of difference in percentage of patients who achieved response as measured by the SLE Responder Index 4 (SRI4) at day 169, along with a sustained reduction of oral corticosteroid (OCS) use between day 85 and day 169. Responses occurred for 34.4% of patients receiving anifrolumab 300mg IV and for 28.8% of patients receiving anifrolumab 1,000mg IV every four weeks versus 17.6% of patients receiving placebo. The trial also met both secondary efficacy endpoints measuring responses at day 365, with even greater effect. Over 50 percent (51.5) of patients receiving anifrolumab 300mg and 38.5% of patients receiving anifrolumab 1,000mg achieved SRI4 response at day 365 with sustained reduction of OCS, compared with 25.5% of patients receiving placebo. The trial also met its other secondary endpoint of a reduction of OCS use to ≤7.5 mg/day by day 365 in those patients taking ≥10 mg/day of OCS at baseline [1].