Ef­forts by the phar­ma­ceu­ti­cal in­dus­try to ex­pand ac­cess to low- and mid­dle-in­come coun­tries need to be “vast­ly ac­cel­er­at­ed” and in some cas­es have fall­en be­hind, ac­cord­ing to a new re­port.

The Ac­cess to Med­i­cine In­dex, which mea­sures how drug­mak­ers make med­i­cines avail­able out­side the wealth­i­est coun­tries, found that per­for­mance across the in­dus­try has di­min­ished over the last two years. The in­dex eval­u­ates the com­pa­nies based on the gov­er­nance of ac­cess, re­search and de­vel­op­ment, and prod­uct de­liv­ery.

No­var­tis was ranked the top com­pa­ny for the first time, while GSK dropped to sec­ond place. Sanofi, Pfiz­er, As­traZeneca and John­son & John­son round­ed out the top five (the last two were tied). The re­port fo­cused on three key find­ings: li­cens­ing and tech­nol­o­gy trans­fers, clin­i­cal tri­al ac­cess, and mak­ing ex­ist­ing prod­ucts avail­able.

The FDA has de­nied Astel­las’ at­tempt to bol­ster the la­bel for its vi­sion loss treat­ment Iz­er­vay with ad­di­tion­al two-year da­ta.

Iz­er­vay, the cen­ter­piece of Astel­las’ $5.9 bil­lion ac­qui­si­tion of Iver­ic Bio, was ap­proved last year to treat ge­o­graph­ic at­ro­phy sec­ondary to age-re­lat­ed mac­u­lar de­gen­er­a­tion. The la­bel calls for month­ly dos­ing capped at 12 months, but Astel­las had hoped that ad­di­tion­al da­ta would sup­port longer use.

Astel­las an­nounced in April that it sub­mit­ted two-year da­ta from a Phase 3 tri­al eval­u­at­ing safe­ty and ef­fi­ca­cy in pa­tients dosed month­ly and every oth­er month. But on Tues­day, it said the FDA is­sued a com­plete re­sponse let­ter over “a sta­tis­ti­cal mat­ter re­lat­ed to la­bel­ing lan­guage pro­posed by Astel­las.”

GSK’s liner­ix­i­bat helped re­duce itch in pa­tients with a rare bile duct dis­ease, meet­ing its pri­ma­ry end­point in a late-stage tri­al.

If ap­proved, liner­ix­i­bat would be the first drug on the US mar­ket to treat itch re­lat­ed to pri­ma­ry bil­iary cholan­gi­tis, a con­di­tion that main­ly af­fects women and can cause liv­er dam­age. It’s al­so as­so­ci­at­ed with a re­lent­less itch that feels like it’s un­der the skin. While first-line pri­ma­ry bil­iary cholan­gi­tis treat­ments may con­trol the dis­ease, they may not re­duce the sever­i­ty of itch­ing, al­so known as pru­ri­tus.

“Pa­tients de­scribe it as bugs crawl­ing, and they want to dig it out,” Megan McLaugh­lin, GSK’s med­i­cine de­vel­op­ment leader for liner­ix­i­bat, told End­points News. 

The FDA hand­ed Chi­nese phar­ma­ceu­ti­cal com­pa­ny Tian­jin Darentang Jing­wan­hong Phar­ma­ceu­ti­cal a warn­ing let­ter af­ter it re­moved in­for­ma­tion from trans­lat­ed man­u­fac­tur­ing records and re­fused to let agency in­spec­tors take pho­tos dur­ing a fa­cil­i­ty vis­it.

Tian­jin Darentang em­ploy­ees in­formed the FDA in­spec­tors they con­cealed in­for­ma­tion af­ter “top man­age­ment” told them to "pro­tect" cer­tain da­ta, which “sig­nif­i­cant­ly hin­dered” the in­spec­tion, ac­cord­ing to the let­ter pub­lished Tues­day. The in­spec­tion took place from March 18 to 22 at the com­pa­ny’s site in the Xiqing Dis­trict in Tian­jin.

Due to the with­hold­ing of in­for­ma­tion, the com­pa­ny did not have prop­er writ­ten in­struc­tions val­i­dat­ing the mak­ing of its over-the-counter prod­ucts. Tian­jin Darentang man­u­fac­tures drugs in­clud­ing burn and scald treat­ments, and oint­ments for di­a­bet­ic pa­tients, tis­sue re­gen­er­a­tion and eczema.