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Safety in Lactation: Drugs for hyperlipidaemias

25 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. There is no evidence for the…
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Refrigerated Storage

PraluentSanofi

Sanofi
Praluent
75mg and 150mg Solution for Injection in pre-filled disposable pen or syringe

In the event of an inadvertent temperature excursion the following data may be used
Praluent can be stored outside the refrigerator (below 25°C) protected from light for a single period not exceeding 30 days. After removal from the refrigerator, the medicinal product must be used within 30 days or discarded. Once the medication has gone above 8°C it can be stored in the refrigerator or outside of the refrigerator below 25 degrees, however, the reduced shelf life must be adhered to.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

if exposed to temperatures described above, reduce the expiry date to 30 days
if exposed to temperatures described above, it can be returned to the fridge or kept at temperatures below 25°C
12 October 2020
London MI Service

Lactation Safety Information

Bile acid sequestrants (if appropriate)
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 large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Possible impact on neonatal development
18 March 2017

New Medicines

PraluentHeterozygous familial hypercholesterolaemia (HeFH) in children aged 8 to 17 years

Information

Praluent
Licence extension / variation
Sanofi
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

PCSK9 inhibitor - PCSK9 is a naturally occurring molecule involved in the regulation of cholesterol levels by modulating low-density lipoprotein cholesterol receptors
There are potentially 4.5 million individuals in Europe with HeFH and probably 35 million worldwide, of whom 20–25% are children and adolescents. Given that there are 255 worldwide births per minute, one baby is born with FH every minute [1].
Heterozygous familial hypercholesterolaemia (HeFH) in children aged 8 to 17 years
Subcutaneous injection

PraluentHomozygous familial hypercholesterolaemia (hoFH) in adults and children - adjunctive therapy

Information

Praluent
Licence extension / variation
Sanofi
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
Launched
Yes
Nov 21SPC updated to advise that experience of alirocumab in paediatric patients is limited to 18 patients aged 8 to 17 years with homozygous familial hypercholesterolaemia. No change has been made to the licensed indication [9].
Apr 21Approved in US as adjunctive treatment in adult patients with HoFH [14].
Jan 21Company appears to have no plans to file for this indication in the UK [13].
Dec 20No information is available to confirm that filing of ODYSSEY HoFH has taken place yet in the EU. It appears that data from the PIII trial in children (NCT03510715) was submitted previously in the EU as these data are now included within the EU SPC, but EMA assessment history documents have yet to be updated to confirm this [9,10,12].
Nov 20The FDA accepts for review the sBLA for HoFH in adults, with a target action date of April 4, 2021. The file was submitted in Q2 20 [12].
Oct 19Filings planned for 2020 [6].
Oct 18Has orphan drug status in US [4].
Jul 18Filings planned for 2022 or later [2].

Category

PCSK9 inhibitor - PCSK9 is a naturally occurring molecule involved in the regulation of cholesterol levels by modulating low-density lipoprotein cholesterol receptors
Homozygous familial hypercholesterolaemia is rare, presents in children and is associated with early death from cardiovascular disease. Homozygous FH has an incidence of approximately one case per million [1].
Homozygous familial hypercholesterolaemia (hoFH) in adults and children - adjunctive therapy
Subcutaneous injection

Trial or other data

Apr 20PIII ODYSSEY HoFH trial results announced, with alirocumab successfully lowering LDL cholesterol. At baseline, more than 95% of participants were on statins (more than 85% on high-intensity statins), more than two-thirds were on ezetimibe, and about 10-15% each on lomitapibe and apheresis. Despite these treatments, baseline LDL cholesterol was 295 and 260 mg/dL, respectively, for the alirocumab and placebo groups. After 12 weeks of treatment, those treated with alirocumab saw a 26.9% drop in LDL cholesterol, equivalent to a mean reduction of 62.8 mg/dL, while the placebo arm reported an increase of 8.6%, or a mean increase of 8.9 mg/dL (mean difference -35.6%; P
Feb 20PIII ODYSSEY HoFH trial completes [11].
Feb 20PIII trial that evaluated the efficacy of alirocumab administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels of treatment in children with hoFH aged 8 to 17 years on top of background treatments completes (NCT03510715). The multicentre, open, prospective trial was initiated in August 2018 and enrolled 18 patients in the Netherlands, Brazil, Canada, Mexico, Russia, Slovenia, Turkey, Denmark, Spain and Taiwan [7].
Jun 19PIII ODYSSEY HoFH trial is still recruiting [5].
Sep 18PIII ODYSSEY HoFH trial is still recruiting [3].
Nov 17PIII ODYSSEY HoFH trial to assess the efficacy of alirocumab in patients with HoFH (Hyperlipoproteinaemia type IIa) who are 12 years of age and older starts (NCT03156621). Percent change in LDL-C from baseline to Week 12 is the defined primary endpoint of the trial. The trial is enrolling 54 patients in South Africa, Japan, Italy, France, Czechia, Canada, US, Austria, Germany, Ukraine, Turkey and Greece. Collection of primary outcome data is due to complete Jan 19 [3].