What You Missed From Regulatory Agencies Last Week — July 7-11, 2014

GSK, Theravance COPD Drug Receives MHLW Approval

GSK and Theravance’s Anoro Ellipta has received a nod of approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW). Anoro Ellipta is indicated to relieve the symptoms caused by airway constriction in COPD, which affects roughly 8.6 percent of Japan’s over-40 population.  The MHLW approved a once daily inhaled dosage of 25 mcg of the umeclidinium and vilanterol combination treatment following review of eight phase 3 clinical trials. This news has also triggered a $10 million milestone that Theravance will pay to GSK. The drug is expected to be released in Q3’14.

Prader-Willi Syndrome Drug Granted Orphan Drug Designation By EC

Zafgen announced that the EC has given its Prader-Willi syndrome (PWS) treatment Beloranib an orphan drug designation. The drug, a first-in-class injectable small molecule MetAP2 inhibitor therapy, is taken to reduce hunger and to encourage the body to use its stored fat as an energy source. The company plans to begin a Phase 3 clinical trial program in PWS in late 2014.

NICE Recommends Lundbeck’s Alcohol Dependence Drug

Lundbeck has received NICE support for its alcohol dependence drug, Selincro (nalmefene). The drug was recommended in a draft guidance for people that are heavy drinkers but do not require immediate detoxification.  The drug performed well in trials last March, earning it an approval in Europe. The drug has been released in the UK, and the company expects that it could be the company’s answer as it faces the loss of patent-protection for its block-buster antidepressant Cipralex/Lexapro (escitalopram oxalate).

Bristol-Myers Squibb Daklinza and Sunvepra approved in Japan

Bristol-Myers Squibb’s dual regimen HCV treatment Daklinza (daclatasvir) and Sunvepra (asunaprevir) was approved by the Japanese Ministry of Health, Labor, and Welfare (MHLW). The drug was approved following a Phase 2 study showing that, for 87 percent of patients, the drug was effective in attaining sustained virologic response 24 weeks after treatment. This approval makes Daklinza+Sunvepra the first all oral, interferon-and ribavirin-free regimen for patients with genotype 1 HCV.

EC grants marketing authorization to GSK CLL Treatment

GSK and Genmab  announced that they received marketing approval from the European Commission for a new indication of its chronic lymphocytic leukemia treatment (CLL) Arzerra in combination with chlorambucil or bendamustine. The EC granted its approval following two different successful clinical trials — one Phase 2 trial and the other a Phase 3 trial — examining ofatumumab (Arzerra) in combination with each chlorambucil and bendamustine.

EMA Awards Preeclampsia Treatment Orphan Drug Designation

A1M Pharma reports that the EMA’s Committee for Orphan Medicinal Products (COMP) and the European Commission formally approved the company’s preeclampsia treatment as an Orphan Drug in Europe. While few details about the treatment have been released, the company says that it is looking into applying for Orphan Drug Designation from the FDA as well.

BioMarin’s Vimizim Receives Health Canada Approval

Vimizim, BioMarin’s enzyme replacement therapy for patients suffering from Morquio A syndrome, was approved by Health Canada. This treatment is the first treatment option in Canada for children and adults afflicted by the syndrome, which causes skeletal and joint abnormalities, among other problems. Vimizim addresses the enzyme deficiency that causes Morquio A. Health Canada received the New Drug Submission application in October 2013 and the review was “fast-tracked” in accordance with the drug’s Priority Review Status.

Pharma Talking points

An article in Time, “Facebook’s Controversial Experiment: Big Tech Is The New Big Pharma,” discusses the role digital media platforms play in research and the gray areas that this kind of research establishes. Time journalist Whitney Erin Boesel argues that there needs to be a new set of basic standards for social and behavioral research. Boesel says these standards must also apply equally to all corporations and institutions, market researchers, academic researchers, and data and social scientists. A new review process as well could help accommodate both the increasingly digitized culture and modern social scientific research methods.

A Reuters article discusses some of the challenges facing those developing antibiotics in a market that undervalues these medicines. The article addresses some of the methods that could be employed to promote antibiotic development in the low-returns antibiotics market. Some of these methods include advanced market commitments, prizes, new research, and patent expansions.

New research published by University of Adelaide argues that vaccines for malaria–like diseases in animals may hold the key for successful development of vaccines for malaria in humans.

Oxbridge Biotech Roundtable discusses the emergence of microRNAs and the role they could play in the treatment of cancer. The article discusses some of the research that has been done that could support the use of these molecules as effective cancer biomarkers.