Campaigners’ fresh safety fears as Zoetis launches new OA treatment

Fresh safety fears have been raised after it emerged that a major pharmaceutical company has sought marketing approval for a new, longer-lasting, canine osteoarthritis (OA) treatment.

Lenivia has already been given the green light for use in Canada, while European authorities are expected to make a final decision in the coming weeks.

The drug’s maker, Zoetis, has claimed it can alleviate pain for three months through a single injection.

But campaigners who allege some of its existing OA products have already harmed tens of thousands of animals have demanded a “moratorium” on approvals until Lenivia and its feline equivalent, Portela, are fully assessed.

Petition

A new petition, launched via the change.org platform, said: “Medicines agencies must ensure that history does not repeat itself (or worse) and that the safety of dogs and cats is given priority over commercial interests and profit.”

Until now, the focus of clinical, public and legal concern has centred on Librela and its equivalent product for cats, Solensia,

Although both Librela and Lenivia are monoclonal antibodies that target nerve growth factor (NGF) to tackle pain, Zoetis claims Lenivia can remain effective for longer because it binds to a different site on the NGF.

In its announcement of Health Canada approval for Lenivia, Zoetis global chief medical officer and head of medical affairs Richard Goldstein said: “We look forward to providing veterinarians with another innovative tool to help them improve the quality of life for the animals in their care.”

The company has now confirmed it is seeking regulatory approval in “additional markets”, but said it could not comment in relation to the UK because of the current lack of authorisation there.

‘Full confidence’

It also reiterated “full confidence” in Librela and Solensia, highlighting that no single reported symptom or outcome from its use is considered more frequent than rare or very rare, according to European Medicine Agency (EMA) standards and based on around 40 million doses distributed up to June of this year.

But the petition, which attracted more than 800 signatures in its first week, said the EMA already had more than 50,000 case reports linked to the two drugs, as of mid-September.

Addressing regulators, including the UK’s VMD, it added: “We urge veterinary medicines agencies across the world to fulfil their responsibility to protect the safety [of] our dogs and cats, and the welfare of their families.” The VMD has refused to say whether it has received an application for Lenivia, citing “commercial sensitivities”.

‘Positive opinion’

But the EMA’s Committee for Veterinary Medicinal Products (CVMP) gave a “positive opinion” of the drug, according to a summary document published following its meeting in early October.

The paper noted that side effects including lethargy and anorexia, which were both classified as “rare”, plus ataxia, polydipsia and polyuria, which were all classed as “uncommon”, had been observed.

But it concluded: “The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Lenivia and therefore recommends the granting of the marketing authorisation.”

The case has now been referred to the European Commission, which is expected to give its final ruling by mid-December.