Lil­ly’s mon­o­clon­al an­ti­body, Taltz, which is al­ready ap­proved for pso­ri­at­ic arthri­tis and plaque pso­ri­a­sis has won its third ap­proval. The FDA has cleared its use in ac­tive anky­los­ing spondyli­tis (AS), a chron­ic in­flam­ma­to­ry rheumat­ic dis­or­der that af­fects the pelvic joints and spine, and can be char­ac­ter­ized by in­flam­ma­to­ry back pain, stiff­ness and im­paired func­tion and mo­bil­i­ty.

Taltz — akin to No­var­tis’ $NVS block­buster Cosen­tyx — in­hibits IL-17A, a cy­tokine in­volved in in­flam­ma­to­ry and im­mune re­spons­es. The drug, which will now al­so ad­dress the rough­ly 1.6 mil­lion Amer­i­cans with AS, gen­er­at­ed about $354 mil­lion in the sec­ond quar­ter.

Taltz was test­ed in two place­bo-con­trolled Phase III stud­ies that en­com­passed 657 AS pa­tients to eval­u­ate the pro­por­tion of pa­tients the drug had an im­pact on, in terms of symp­toms of pain, in­flam­ma­tion and func­tion at 16 weeks. In the COAST-V tri­al, which in­clud­ed pa­tients who had nev­er been treat­ed with an an­tirheumat­ic bi­o­log­ic, 48% of Taltz-treat­ed pa­tients achieved the re­sponse every four weeks ver­sus 18% of place­bo-treat­ed pa­tients (p<0.0001). In COAST-W tri­al, which in­volved pa­tients who did not ad­e­quate­ly ben­e­fit or were in­tol­er­ant to tu­mor necro­sis fac­tor (TNF) in­hibitors, 25% of pa­tients treat­ed with Taltz every four weeks achieved a re­sponse, ver­sus 13% of pa­tients giv­en the place­bo (p<0.05).

Four months ago, Lil­ly’s $LLY Taltz al­so cleared a late-stage study called COAST-X, in pa­tients with a form of in­flam­ma­to­ry arthri­tis in which there is no vis­i­ble ev­i­dence of dam­age on X-rays — non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis (nr-AxS­pA).

Cosen­tyx is al­so ap­proved for AS, as is UCB’s TNF block­er Cimzia.

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.