Last Ju­ly, the cost-ef­fec­tive­ness drug watch­dog ICER re­leased a pre­lim­i­nary draft re­port that Vivus’ Qsymia was the most cost-ef­fec­tive op­tion for weight loss. That de­ci­sion has now been val­i­dat­ed.

ICER made its fi­nal de­ter­mi­na­tion Wednes­day that Qsymia, the brand name for the ap­petite sup­pres­sant phen­ter­mine com­bined with an­ti­con­vul­sant top­i­ra­mate, was more cost-ef­fec­tive for weight loss than oth­er com­peti­tors such as No­vo Nordisk’s Sax­en­da (li­raglu­tide) and We­govy (semaglu­tide) or Cur­rax Phar­ma­ceu­ti­cals’ Con­trave (bupro­pi­on/nal­trex­one).

Per ICER:

At cur­rent prices and with com­mon­ly ac­cept­ed cost-ef­fec­tive­ness bench­marks, re­sults sug­gest that phen­ter­mine/top­i­ra­mate in ad­di­tion to lifestyle mod­i­fi­ca­tion is cost ef­fec­tive com­pared with lifestyle mod­i­fi­ca­tion alone. The cost ef­fec­tive­ness of treat­ment of obe­si­ty with semaglu­tide or li­raglu­tide, in pa­tients with­out di­a­betes mel­li­tus, ex­ceeds com­mon­ly used thresh­olds.

The watch­dog men­tioned that the health-ben­e­fit price bench­mark for the more fa­mous semaglu­tide, which al­so was more ef­fec­tive than the oth­er No­vo Nordisk drug and Con­trave, is $7,500 to $9,800 per year. But at its cur­rent price point, it would re­quire the drug be dis­count­ed some­where be­tween 44-57% of its whole­sale price.

ICER re­view­ers al­so added that if Qsymia wasn’t per­form­ing well in cer­tain pa­tients, Con­trave may be the next best cost-ef­fec­tive op­tion. The re­view­ers not­ed in their re­port that there were a few lim­i­ta­tions to analy­sis, in­clud­ing the full im­pact of the drugs in pa­tients with chron­ic kid­ney dis­eases or con­di­tions where weight loss may be ben­e­fi­cial.

Vivus nabbed ap­proval for Qsymia in adults in 2012, fol­lowed by a tu­mul­tuous his­to­ry that end­ed up with Vivus fil­ing for bank­rupt­cy. Years lat­er, the FDA ex­pand­ed Qsymia’s weight loss in­di­ca­tion from just adults to use in ado­les­cents. How­ev­er, the reg­u­la­to­ry agency added the con­di­tion that the drug is giv­en on top of both a re­duced-calo­rie di­et and in­creased phys­i­cal ac­tiv­i­ty.

Vivus CEO John Amos told End­points News last month af­ter ICER’s draft re­port that so far, Qsymia is av­er­ag­ing around $40 mil­lion to $42 mil­lion in an­nu­al sales and in the range of 400,000 scripts every year. And in ap­provals, Qsymia has been ap­proved out­side the US in South Ko­rea, the five Nordic coun­tries and Poland — with more ap­provals pend­ing in oth­er Eu­ro­pean coun­tries such as the UK.

ICER’s de­ci­sion comes the same week Cur­rax launched a new ad cam­paign for Con­trave, fo­cused on the drug as a choice for emo­tion­al eat­ing con­nect­ed to obe­si­ty and over­weight con­di­tions.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.