In a historic move, the government has announced that from April PrEP (pre-exposure prophylaxis) will be routinely available across England, in line with plans to end HIV transmission by 2030.
Health and social care secretary Matt Hancock confirmed that local authorities will receive £16 million in 2020 to 2021 to deliver the preventative HIV treatment across the country.
The funding, from the Department of Health and Social Care, will ensure anyone who is at a high risk of contracting the virus will receive PrEP from their local sexual health clinic in a bid to eliminate its spread.
PrEP, which can cut the risk of contracting HIV from sex by around 99% when taken daily, is currently available in England through the NHS funds Novartis' Ilaris three-year PrEP impact trial, which has recruited over 20,000 participants. The new funding will ensure that everyone can remain on the treatment after the trial's completion.
Applauding the move, Ian Green, chief executive at the Terrence Higgins Trust, said: “We know PrEP is highly effective at stopping HIV and now it can be properly utilised to make good on the Government’s commitment to ending HIV transmissions by 2030." But he also stressed that “there is still also a lot of work to do to ensure PrEP isn’t just seen as something for gay and bisexual men and that its clear benefits reach other groups affected by HIV, including women, trans people and BAME communities.”
An estimated 103,800 people were living with HIV in the UK in 2018, with 7,500 of those unaware of their infection, the government said.

Shionogi & Co has launched Mulpleo (lusutrombopag) in the UK for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing invasive procedures.
The decision marks the first licensed treatment available on the NHS in the UK to treat this condition, with the drug having been approved for funding across the health services in England, Wales, Scotland and Northern Ireland.
The company says the approval and launch of the drug is based on evidence from the L-PLUS 1 and L-PLUS 2 trials, in which Mulpleo met the pre-specified primary endpoint and all key secondary endpoints with statistically significant results.
“The number of people with chronic liver disease has increased significantly in recent years and we expect this trend to continue,” said Dr Andrew Holt, a consultant physician. “Until now, there have been no specific therapies available to treat thrombocytopenia, a common blood-related complication of chronic liver disease which can complicate or delay crucial interventions for these patients. Physicians now have an effective tool to help enable these interventions to go ahead safely and when planned.”

Alnylam has received EU approval to market its RNAi therapeutic Givlaari (givosiran) for the ultra-rare genetic condition acute hepatic porphyria (AHP), to address debilitating attacks of severe abdominal pain, vomiting and seizures in patients aged 12 years and older. Clearance is based on data from the Phase III ENVISION trial, which showed a 74% cut in the rate of porphyria attacks. The approval “marks a historic moment for patients and families ... as there are currently no approved medicines in Europe proven to decrease the frequency of attacks and reduce the chronic pain that many patients suffer,” said John Maraganore, Alnylam's chief executive.

The EC has approved a combination of AbbVie's Venclyxto (venetoclax) and Roche's Gazyvaro (obinutuzumab) for adults with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows a primary analysis of the pivotal Phase III CLL14 study, in which the combination led to a 65% reduction in the risk of disease worsening or death, as well as doubling complete response rates. The combo is the “first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development.

The EMA has granted both PRIME (PRIority MEdicines) and Advanced Therapy Medicinal Product (ATMP) designations to Janssen's adeno-associated virus (AAV)-RPGR gene therapy product, for the treatment of inherited retinal disease X-linked retinitis pigmentosa (XLRP). The novel drug, which is being jointly developed with MeiraGTx Holdings, has also received Fast Track designation in the US and orphan designations from the FDA and the EMA. Currently there are no approved treatments for XLRP; Janssen's gene therapy is designed to treat the most common form of the disease, caused by mutations in the RPGR gene, by slowing the retinal degeneration and preserving visual function.

Novo Nordisk has paused the Phase III explorer7 and explorer8 trials for haemophilia drug concizumab, due to non-fatal thrombotic events. The Danish drugmaker confirmed that no additional patients will be recruited, and further treatment of those currently enrolled in trials with the drug will cease while further investigation into these events takes place. The studies, in addition to the Phase II explorer5 trial, were evaluating prophylactic use of concizumab in haemophilia A and B patients regardless of inhibitor status. An independent data monitoring committee is in the process of assessing the relevance of the events to the continuation of the programme.

Bristol-Myers Squibb says adding Empliciti (elotuzumab) to Revlimid (lenalidomide) and dexamethasone has not proved successful in extending the time patients with newlydiagnosed myeloma who were ineligible for bone marrow transplant lived without their disease worsening. The Phase III ELOQUENT-1 trial did not meet its primary endpoint of progression-free survival versus Revlimid and dexamethasone alone. BMS’ Noah Berkowitz, head of clinical development for its haematology unit, said the firm is disappointed, but stressed that “Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma”.

MedDay Pharmaceuticals has announced top-line data showing that experimental drug MD1003 missed both primary and secondary endpoints of the Phase III SPI2 trial. The study, evaluating the drug in patients with non-active progressive multiple sclerosis (MS), was designed to confirm positive results of the Phase III MS-SPI trial, which also assessed the ability of MD1003 to reverse disease progression in progressive MS. The main measure of the study was an improvement in disability, with either a lower EDSS score or a reduction in the time to walk 25 feet. However, there was ultimately no improvement in either of these measures in comparison to the placebo group.