Benzathine benzylpenicillin

323404007

New Medicines

Penicillin-sensitive bacterial infections including syphilis, rheumatic fever, post-streptococcal glomerulonephritis, erysipelas

Information

New molecular entity
Brancaster Pharma
Not Known

Development and Regulatory status

Launched
None
None
February 2020
Feb 20 · Licence is for use in adults, adolescents, children and neonates for treatment of erysipelas, early syphilis (primary and secondary), latent syphilis (except for neurosyphilis and presence of pathological CSF findings), yaws and pinta. Also for the prophylaxis of rheumatic fever (chorea, rheumatic carditis), poststreptococcal glomerulonephritis and erysipelas [7].
Feb 20 · Launched in the UK. Price 1 vial of 1.2 million I.U or 2.4 million I.U £9.50 [6].
Jul 19 · Approved by MHRA [5].
May 19 · Brancaster now expecting a CHMP opinion in Mar 2019 but no information available on the decision [4].
Mar 18 · Brancaster expects the EU CHMP to issue an opinion on approval of their benzathine benzylpenicillin by end of 2018 [2].

Category

Penicillin antibiotic as 0.6 MIU, 1.2 MIU and 2.4 MIU powder and solvent for suspension for injection
There were 5,288 new diagnoses of syphilis in England in 2015, a 19.9% increase from 4,412 in 2014. This represented the biggest increase of any sexually transmitted infection in 2015 [1].
Penicillin-sensitive bacterial infections including syphilis, rheumatic fever, post-streptococcal glomerulonephritis, erysipelas
Intramuscular

Trial or other data

Mar 18 · There is currently no licensed benzathine benzypenicillin available in the UK; all stock has to be imported [3].