Late-December TGA additions you might have missed.
Five new additions to the Prescription Medicines in Pregnancy database landed on Christmas eve last year.
The medications treat eczema, cystic fibrosis, hyperphenylalaninaemia (HPA), myeloma and skin necrosis.
Belantamab mafodotin (Blenrep) is an antibody-drug conjugate (ADC) which was added to the Australian Register of Therapeutic Goods (ARTG) in November last year.
It is the first in a new family of medicines used to treat myeloma in adults and has been given a D pregnancy category in the database.
This category indicates the medicine could cause an increased incidence of human fetal malformations or irreversible damage.
Vanzacaftor + Tezacaftor + Deutivacaftor (Alyftrek) was also added to the ARTG in November and has been given a B3 pregnancy category.
It is a cystic fibrosis transmembrane conductance regulator (CFTR) modulator for use in adults and children from six years of age.
It was categorised B3 because it has been taken by a limited number of pregnant women without harmful effects, but animal studies have shown an increased occurrence of fetal damage associated with its use.
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Anacaulase-bcdb (Nexobrid), Sepiapterin (Sephience) and Delgocitinib (Anzupgo) were all given a B1 pregnancy category, meaning animal studies have shown no increased occurrence of fetal damage and they have been taken by a limited number of pregnant women without causing an increased frequency of fetal malformations.
Anacaulase-bcdb was added to ARTG in September 2025 and is a topical treatment for eschar removal in adults and paediatric patients following deep partial thickness or full thickness burns.
Sepiapterin, an oral powder used to treat HPA in adult and paediatric patients with phenylketonuria, was added to the ARTG in July last year.
The topical treatment delgocitinib was added to the ARTG in September. It treats moderate to severe chronic hand eczema in adults where topical corticosteroids are ineffective or inappropriate.
Full details from the TGA are available here.
