Monoclonal antibody used for IgE-mediated allergic asthma

No published evidence of safety

Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract, although long half-life increases risk of accumulation in breastfed infant

Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven

Dec 20 · Approved in US [12].

Jul 20 · Approved in EU [11]

Jun 20 · Recommended for EU approval by CHMP - the additional indication is "as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP [Chronic rhinosinusitis with nasal polyps] for whom therapy with INC does not provide adequate disease control" [10].

Dec 19 · The FDA has accepted a supplemental Biologics License Application (sBLA) for omalizumab for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids [8].

Nov 19 · Novartis submitted to the European Medicines Agency a Type II variation application for Xolair for the treatment of nasal polyps. A decision is expected in 2020 [9].

Oct 18 · EU & US filings now planned for 2019 [5].

Mar 18 · Filings planned for 2020 [4].

Nasal polyps are lesions arising from the nasal mucosa, occurring at any site in the nasal cavity or paranasal sinuses but most frequently seen in the clefts of the middle meatus. Nasal polyps can be considered as part of the spectrum of chronic rhinosinusitis. The population prevalence is reported as around 4%, with no racial predilection. The male-to-female ratio is approximately 2:1 [1].

Feb 21 · POLYP 1 and 2 published in J Allergy Clin Immunol 2020; 146(3): 595-605 [13].

Jun 19 · Competing with dupilumab for nasal polyps. Xolair is also being investigated as a treatment for food allergies (US Breakthrough Therapy designation) and seasonal allergic rhinitis [7]

Jun 19 · Positive topline data announced from two PIII trials of Xolair (omalizumab) for adults with chronic rhinosinusitis with nasal polyps. The POLYP 1 and 2 trials both met co-primary endpoints and key secondary endpoints.[6]

Dec 18 · Recruitment complete in PIII trials, POLYP 1 and POLYP 2 [5].

Dec 17 · Roche initiates two PIII trials to evaluate the efficacy and safety of omalizumab compared with a placebo each in 120 patients with chronic rhinosinusitis with nasal polyps (POLYP 1, NCT03280550; POLYP 2, NCT03280537) who have had an inadequate response to standard of care treatments. Sites include the US & EU and collection of primary outcome data (change from baseline in average daily nasal congestion score at 24 weeks, and in nasal polyp score at 24 weeks) should complete May 19 [2,3].

EPAR

NICE draft scope

NIHR

NTAG

NTAG

SMC

Severe asthma is a specific type of asthma that does not respond to current readily available treatments, rather than simply an extreme form of the condition, and affects around 200,000-250,000 people in the UK. Around 40% of people with asthma have the eosinophilic form [1].

Food allergy is thought to affect 5 in 100 young children and 3-4 in 100 adults in westernised countries. Levels of food allergy seem to be rising. Reasons for this are unclear but it may be connected with the processed nature of the western diet and its effects on the gut microbiome. It is difficult to find accurate numbers for prevalence of food intolerance or allergy [1].