Valorem Life Sciences

Priority review for Sanofi, Regeneron’s Dupixent

Posted on November 8th, 2018

Sanofi and Regeneron’s biologic Dupixent has been granted a priority review in the US for use to treat certain adolescent patients with moderate-to-severe atopic dermatitis.

The companies are seeking approval to market the drug for patients aged 12 to 17 years whose disease is inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable.

Dupixent (dupilumab) inhibits interleukin-4 and interleukin-13 (IL-4 and IL-13) signaling, two key drivers of Type 2 inflammation, a systemic response known to play a role in moderate-to-severe atopic dermatitis.

In one clinical trial, 24% of patients who received weight-based dosing of Dupixent every two weeks and 18% of those given a fixed dose every four weeks achieved the primary endpoint of clear or almost-clear skin, versus 2% in the placebo arm.

Also, 41.5% of those who received Dupixent every two weeks and 38 percent of patients who took the drug every four weeks achieved 75% or greater skin improvement (EASI-75) compared to 8% in the control group.

On the safety side, the overall rate of adverse events was comparable between the Dupixent groups and placebo (72% for Dupixent every two weeks, 64% for Dupixent every four weeks and 69% for placebo) over the 16-week treatment period, while there were no serious adverse events or events leading to treatment discontinuation in either drug treatment group.

Dupixent was approved in the US in March last year for the treatment of adults with moderate-to-severe atopic dermatitis, and just days ago won clearance for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Its approval for adolescents with moderate-to-severe atopic dermatitis could help address significant unmet medical need for this patient group, who have no approved systemic biologic medications.

A decision by the US Food and Drug Administration is expected by March 11, 2019.

Source: Pharma Times

Tusk Therapeutics to be acquired by Roche

Posted on September 28th, 2018

Tusk Therapeutics Ltd (“Tusk”) was today acquired by Roche. Tusk has developed an antibody with a novel mode of action aimed at depleting regulatory T-cells (Tregs). Tregs suppress immune responses, including those against cancer cells. Preclinical data has shown that depleting Tregs from the tumor microenvironment can enhance and/or restore anti-tumor immunity. Tusk’s antibody has been designed to deplete these harmful Tregs, while not interfering with other immune cells acting against the tumor. Tusk’s program is expected to start clinical trials in cancer patients towards the end of 2019.

Tusk was founded in 2014 by Droia Oncology Ventures, Tusk’s majority shareholder. Under the terms of the agreement, Tusk’s shareholders will receive an upfront cash payment of Euro 70 million, plus additional contingent payments of up to Euro 585 million based on achievements of certain predetermined milestones.

Luc Dochez, Chief Executive Officer of Tusk Therapeutics, said: “We are delighted that Roche will further develop this novel antibody and drive the development ahead. The remaining portfolio of our immune-oncology targets will be further developed by Black Belt Therapeutics, a newly formed company spun out of Tusk Therapeutics.”

Source: GlobeNewsWire

PAH patients in England denied access to Actelion’s Uptravi on NHS

Posted on July 10th, 2018

Actelion’s Uptravi will not be funded on the NHS for patients with Pulmonary Arterial Hypertension (PAH), after the drug failed to make it into NHS England’s latest round of specialised commissioning approvals.

The drugmaker has slammed the decision, which it argues will delay access to Uptravi (selexipag) as a combination treatment for PAH in adult patients with one of the more severe forms of the disease who are insufficiently controlled on oral treatment.

“This ruling will create a disparity in access to selexipag throughout the UK, with patients in Scotland and Wales already having access,” it stressed.

The Scottish Medicines Consortium backed NHS funding for the drug back in May, but restricted its use to combination therapy in a sub-population of patients with PAH specifically those in WHO FC III who are insufficiently controlled with an ERA and a PDE-5 inhibitor and who would be considered for treatment with inhaled iloprost.

This was followed by a green light from the All Wales Medicines Strategy Group (AWMSG) in June, which recommended the drug as part of a triple combination therapy for the treatment of the condition, in adults with one of the more severe forms of the disease who are insufficiently controlled on oral treatment with two other classes of PAH medicines.

PAH is a progressive disease with high rates of morbidity and mortality affecting around 6,000-7,000 people in the UK. It is characterised by abnormally high blood pressure in the arteries between the heart and lungs, causing symptoms such as such as breathlessness, fatigue, weakness and angina.

While options are available to address these symptoms there is currently no treatment that slows progression or cures the disease, and fewer than 40 percent of patients live beyond five years of diagnosis.

Uptravi’s European approval in May 2016 came on the back of data from the Phase III GRIPHON study showing that the drug, a selective IP prostacyclin receptor agonist, delayed the time to a first morbidity or mortality event compared to placebo.

In the trial, exposure to the drug was up to 4.2 years with a median duration of exposure of 1.4 years; the risk of this primary composite end-point was reduced by 40 percent with Uptravi compared to placebo (a relative risk reduction of 16 percent).

“Selexipag is a step-change in the treatment of these patients as it is the first oral medicine targeting the important prostacyclin pathway, which offers hope for those who have had insufficient benefit from existing oral treatments. It is therefore extremely disappointing that PH clinicians will not be able to offer this treatment to patients,” said Dr John Wort, clinical lead for pulmonary hypertension at the Royal Brompton & Harefield NHS Trust.

Also expressing disappointment at NHS England’s decision, Dr Iain Armstrong, chair, Pulmonary Hypertension Association UK called for an “urgent review” on decisions regarding new therapies available for PH currently blocked or deferred by national funders.

“As a PH community we don’t ask for much; we just want the same equality and access to treatment as other disease areas like cancer. We are extremely disappointed by this decision and as a dynamic patient organisation we will continue to fight for equality and equity of access to service provision in the UK.”

Source: Pharma Times