dm+d

Unassigned

New Medicines

SpevigoGeneralised pustular (GPP) psoriasis - intravenous injection

Information

Spevigo
New molecular entity
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

None
Pre-registration (Filed)
Approved (Licensed)
Sep 22Approved in US for the treatment of generalized pustular psoriasis flares in adults. Boehringer plan to launch Spevigo early next week [7].
Dec 21Boehringer Ingelheim announces that the FDA has accepted a BLA and granted Priority Review for spesolimab for the treatment of generalized pustular psoriasis (GPP) flares. The FDA has granted spesolimab Orphan Drug Designation for the treatment of GPP, and Breakthrough Therapy Designation for spesolimab for the treatment of GPP flares in adults [4].
Nov 21Filed in EU via centralised procedure [3].

Category

A humanised monoclonal antibody, targeting interleukin 36 (IL-36) receptor
It is a rare condition: precise prevalence figures for the UK are not available. Prevalence is 7 per 1 million in Japan. The average age of those affected is 50 but the range is wide [1].
Generalised pustular (GPP) psoriasis - intravenous injection
Intravenous

Further information

Yes

Trial or other data

Jan 22PII trial (NCT03782792, n= 53) reports spesolimab resulted in a higher incidence of lesion clearance at 1 week than placebo (43% had GPPGA total score of 0 or 1, vs. 11% placebo; p=0.02).but was associated with infections and systemic drug reactions [6].
Dec 21Results of PII NCT03782792 study are published in NEJM [5].
May 19PIII study to evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have completed previous BI 655130 trials and are qualified for entry in this trial starts (NCT03886246). Collection of primary outcome data due to complete Sep 27 [2].
Jan 19PII study to evaluate efficacy, safety, and tolerability of BI 655130 compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity starts (NCT03782792). 51 adults will be recruited in countries including the US & EU (not UK). Collection of primary outcome data (A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 1) due to complete Dec 20 [2].

Evidence based evaluations

Ulcerative colitis (UC) in patients who have failed previously biologic therapy

Information

New molecular entity
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A humanised monoclonal antibody, targeting interleukin 36 (IL-36) receptor
Ulcerative colitis is the most common type of inflammatory disease of the bowel. It has an incidence in the UK of approximately 10 per 100,000 people annually and a prevalence of approximately 240 per 100,000 [1].
Ulcerative colitis (UC) in patients who have failed previously biologic therapy
Subcutaneous and
Intravenous